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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019820-30 | EudraCT Number |
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The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomalidomide + Low-Dose Dexamethasone | Experimental | Participants received 4 mg pomalidomide administered by mouth on Days 1 to 21 of each 28-day treatment cycle and 40 mg dexamethasone (or 20 mg for participants > 75 years of age) administered by mouth once per day on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression. |
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| High-Dose Dexamethasone | Active Comparator | Participants received 40 mg dexamethasone (or 20 mg for participants > 75 years of age) administered by mouth once per day on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day treatment cycle until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pomalidomide | Drug | 4 mg pomalidomide capsules administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) - Primary Analysis | Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease required 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. | From randomization until the data cut-off date of 07 September 2012. Maximum duration of follow-up for PFS assessments was 57 weeks. |
| Progression-free Survival (PFS) With a Later Cut-off Date | Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease requires 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. | From randomization until the data cut-off date of 01 March 2013. Maximum duration of follow-up for PFS assessments was 74 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death. |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following laboratory abnormalities:
Previous therapy with pomalidomide
Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
Resistance to high-dose dexamethasone used in the last line of therapy
Peripheral neuropathy ≥ Grade 2
Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
Subjects who are planning for or who are eligible for stem cell transplant
Subjects with any one of the following: 1) Congestive heart failure, 2) Myocardial infarction within 12 months prior to starting study treatment, 3) Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
Subjects who received any of the following within the last 14 days of initiation of study treatment: 1) Plasmapheresis, 2) Major surgery, 3) Radiation therapy, 4) Use of any anti-myeloma drug therapy
Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment
Subjects with conditions requiring chronic steroid or immunosuppressive treatment
Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form
Pregnant or breastfeeding females
Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis A, B, or C
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| Name | Affiliation | Role |
|---|---|---|
| Lars Sternas, MD, PhD | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Royal Adelaide Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27173785 | Result | Moreau P, Weisel KC, Song KW, Gibson CJ, Saunders O, Sternas LA, Hong K, Zaki MH, Dimopoulos MA. Relationship of response and survival in patients with relapsed and refractory multiple myeloma treated with pomalidomide plus low-dose dexamethasone in the MM-003 trial randomized phase III trial (NIMBUS). Leuk Lymphoma. 2016 Dec;57(12):2839-2847. doi: 10.1080/10428194.2016.1180685. Epub 2016 May 13. | |
| 24007748 |
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Participants were randomized in a 2:1 ratio. Treatment phase discontinuation occurred when a participant had confirmed progressive disease. Participants who did not progress but who were intolerant to treatment, or no longer wished to receive study treatment entered the progression-free survival (PFS) follow-up period until disease progression.
The study was conducted at 93 sites: 68 sites in Europe, 10 sites in Australia, 10 sites in Canada, 4 sites in Russia, and 1 site in the United States (US) from 18 March 2011 to 29 August 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pomalidomide Plus Low-Dose Dexamethasone | Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
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| Dexamethasone | Drug | 40 mg dexamethasone (or 20 mg for participants > 75 years of age) tablets administered orally |
|
| From first dose of study drug through to 30 days after the last dose as of the end of the study (29 August 2017); maximum time on treatment was 297, 269, and 239 weeks in the Pomalidomide + LD-Dex, HD-Dex, and cross-over groups respectively. |
| Overall Survival - Primary Analysis | Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. | From randomization until the data cut-off date of 07 September 2012. Maximum time on follow-up for survival was 70 weeks. |
| Overall Survival With a Later Cut-off Date | Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up for survival was 93 weeks. |
| Overall Survival Based on the Final Dataset | Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. | From randomization until the data cut-off date of 29 August 2017. Maximum time on follow-up for survival was 324 weeks. |
| Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria | Objective response is defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on the Independent Response Adjudication Committee: SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
| Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria | Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the Independent Response Adjudication Committee: CR requires all of the following: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions. | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
| Time to Progression | Time to progression (TTP) is calculated as the time from randomization to the first documented progression confirmed by a blinded, independent Response Adjudication Committee and based on the International Myeloma Working Group Uniform Response criteria (IMWG). Progressive disease requires 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
| Time to Response | Time to response is calculated as the time from randomization to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required. | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
| Duration of Response | Duration of response (calculated for responders only) is defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria assessed by the Independent Response Adjudication Committee. | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
| Time to the First Hemoglobin Improvement | Time to increased hemoglobin, defined as the time from randomization to at least one category improvement from Baseline in common terminology criteria for adverse events (CTCAE) grade for hemoglobin level. Hemoglobin categories are: 1) Normal; 2) CTCAE Grade 1: < lower limit of normal (LLN) to 10.0 g/dL; 3) CTCAE Grade 2: < 10.0 to <8.0 g/dL. Participants with CTCAE Grade 3 anemia or worse at Baseline were excluded from the study. | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
| Time to Improvement in Bone Pain | Time to improvement in bone pain is defined as the time from randomization to at least one category improvement from Baseline in bone pain category. Bone pain was categorized (from best to worst) according to answers to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for patients with Multiple Myeloma Module (QLQ-MY20), Question 1, "Have you had bone aches or pain?": 1) Not at all, 2) A little, 3) Quite a bit, or 4) Very much. | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
| Time to Improvement in Renal Function | Time to improvement in renal function is defined as the time from randomization to at least one category improvement from Baseline in renal function. Renal Function was categorized as (from best to worst): - Normal: creatinine clearance ≥80 mL/min; - Grade 1: creatinine clearance ≥60 to <80 mL/min; - Grade 2 : creatinine clearance ≥45 to < 60 mL/min. Participants with creatinine clearance < 45 mL/min at baseline were excluded from the study. | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
| Time to Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status | Time to improvement in ECOG performance status defined as the time from randomization until at least a one category improvement from Baseline in ECOG performance status score. The categories of the ECOG Performance Status Scale are as follows: -0: Fully active, able to carry on all pre-disease performance without restriction; -1: Restricted in physically strenuous activity but ambulatory and able to carry our work of a light or sedentary nature, e.g., light housework, office work; -2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. Patients with a score of 3, 4 or 5 were excluded from participating in the study. | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
| Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement. | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
| Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
| Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
| Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom). | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
| Change From Baseline in the EORTC QLQ-C30 Pain Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reductions in pain (i.e. improvement in symptom) and positive values indicate increases in pain (i.e. worsening of symptom). | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
| Change From Baseline in the European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms | The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective). The EORTC QLQ-MY20 Disease Symptoms Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction (i.e. improvement) in symptoms and positive values indicate increase (i.e. worsening) of symptoms. | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
| Change From Baseline in the EORTC QLQ-MY20 Side Effects Domain | The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective). The EORTC QLQ-MY20 Side Effects Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction in side effects (i.e.improvement in symptom) and positive values indicate increase in side effects (i.e. worsening of symptom). | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
| Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Utility Index Score | EQ-5D is a self-administered questionnaire that assesses health-related quality of life (QOL). The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where an EQ-5D score of 1.00 equals "perfect health", a score of 0 equals "death" and a score of -0.59 equals worst imaginable health state. A positive change from Baseline score indicates improvement in health status. A negative change from Baseline score indicates worsening in health status. Negative scores represent the possible though unlikely situation that a patient's QOL is worse than death, i.e. they would rather be dead than living with that QOL | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
| Time to First Worsening of Quality of Life (QOL) Domains | Time to worsening in quality of life domains was calculated as the time from Baseline to the first worsened minimally important difference (MID), defined as the smallest change in a QOL score considered important to patients that would lead the patient or clinician to consider a change in therapy. MID thresholds were calculated in Standard Error of Measurement (SEM) units using the Baseline QOL data. Based on the MID, participants were classified as worsened according to the following: For the EORTC QLQ-C30 global health status and functional scales and the EQ-5D health utility score, participants were classified as worsened if their change from Baseline score was less than -1 SEM. For the EORTC QLQ-C30 symptom scores (fatigue and pain) and EORTC QLQ-MY20 disease symptoms and side effects scales, participants were classified as worsened if their change from Baseline score was greater than 1 SEM. See previous outcome measures for definitions of each scale. | Assessed on Day 1 of the first 6 treatment cycles. |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Peter MacCallum Cancer Institute | East Melbourne | Victoria | 3002 | Australia |
| Frankston Hospital | Frankston | Victoria | 3199 | Australia |
| Princess Alexandra Hospital | Brisbane | QLD4102 | Australia |
| Royal Prince Alfred Hospital | Camperdown | 2050 | Australia |
| Alfred hospital | Melbourne | 3004 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | 6009 | Australia |
| Calvary Mater Hospital | Waratah | NSW 2298 | Australia |
| Border Medical Oncology | Wodonga | 3690 | Australia |
| Wollongong Hospital | Wollongong | 2500 | Australia |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHU UCL Mont-Godinne-Dinant asbl | Yvoir | B-5530 | Belgium |
| Tom Baker Cancer Center | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| British Columbia Cancer Agency | Vancouver | British Columbia | V5Z 4E6 | Canada |
| James Cancer Hospital | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| London Health Sciences Centre | London | Ontario | N6C 6B5 | Canada |
| University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| Maisonneuve Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Royal Victoria Hospital McGill Department of Oncology(RVH) | Montreal | Quebec | H3A 1A1 | Canada |
| Sir Mortimer B. Davis - Jewish Genl | Montreal | Quebec | H3T 1E2 | Canada |
| Charles University General Hospital | Prague | 128 08 | Czechia |
| Hæmatologisk afd. B Aalborg Sygehus Syd | Aalborg | 9000 | Denmark |
| Aarhus University Hospital | Arhus C | DK-8000 | Denmark |
| Odense Universitetshospital | Odense C | 5000 | Denmark |
| Vejle Hospital | Vejle | 7100 | Denmark |
| CHU d'Angers | Angers | 49033 | France |
| Centre Hospitalier de la cote basque | Bayonne | 64109 | France |
| Centre Hospitalier Departemental | La Roche-sur-Yon | 85025 | France |
| CHRU de Lille FR | Lille | 59037 | France |
| Institut Paoli-Calmettes | Marseille | 13009 | France |
| CHRU Nantes | Nantes | 44093 | France |
| Hopital Saint-Louis | Paris | 75475 | France |
| CHU Hôpital St-Antoine | Paris | 75571 | France |
| CHRU - Hopital du Haut Leveque | Pessac | 33604 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| Hopital Bretonneau | Tours | 37044 | France |
| Hopital Purpan | Tulouse Cedex 9 | 31059 | France |
| CHU Nancy | Vandœuvre-lès-Nancy | 54511 | France |
| Universitatsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Universitatsklinikum Essen | Essen | 45122 | Germany |
| Askepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Universitatsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitatsklinikum Jena | Jena | 07740 | Germany |
| Universitatsklinikum Leipzig | Leipzig | 04103 | Germany |
| University of Tubingen | Tübingen | 72076 | Germany |
| Universitatsklinikum Ulm | Ulm | 89081 | Germany |
| Universitatsklinikum Wurzburg | Würzburg | 97080 | Germany |
| Alexandra General Hospital of Athens | Athens | 11528 | Greece |
| Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi | Bologna | 40138 | Italy |
| Clinica Ematologica- A.O.U. San Martino | Genova | 16132 | Italy |
| Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale | Naples | 80131 | Italy |
| AOU San Luigi Gonzaga | Orbassano | 10043 | Italy |
| Universita degli Studi di Padova | Padova | 35128 | Italy |
| Hospital Clinic | Placenza | 29100 | Italy |
| Servizio di Ematologia, A.O. - Arcispedale S.Maria Nuova | Reggio Emilia | 42100 | Italy |
| Univerita La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia | Rome | 00161 | Italy |
| Azienda Ospedaliera San Giovanni Battista | Torino | 10126 | Italy |
| VU University Medical Center | Amsterdam | 1081 HV | Netherlands |
| Erasmus Medical Center | Rotterdam | 3015 CE | Netherlands |
| University Medical Center Utrecht | Utrecht | 3584 CX | Netherlands |
| State Institution Hematological Research, Centre of Russian Academy of Medical Science | Moscow | 125167 | Russia |
| State Institution Moscow Regional Research Clinical Institute | Moscow | 125284 | Russia |
| St. Petersburg Research Institute of Hematology and Blood Transfusion | Saint Petersburg | 191024 | Russia |
| State Educational Institution, Saint Petersburg State Medical University | Saint Petersburg | 197022 | Russia |
| Hospital Universitari Germans Trias i Pujol | Badalona (Barcelona) | 08916 | Spain |
| Hospital Clinic Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital de La Princesa | Madrid | 28006 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Donostia | San Sebastián (Guipuzcoa) | 20014 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | 39008 | Spain |
| Hospital de la Fe | Valencia | 46009 | Spain |
| Department of Hematology Hematology Centre | Gothenburg | S-413 45 | Sweden |
| University Hospital in Lund | Lund | 221 85 | Sweden |
| Karolinska University Hospital Huddinge | Stockholm | SE 17176 | Sweden |
| Karolinska University Hospital | Stockholm | SE-171 76 | Sweden |
| Overlakare Medocomcentrum, hematologi | Uppsala | 75185 | Sweden |
| Medizinische Universitatsklinik | Bern | CH - 3010 | Switzerland |
| Hopitaux Universitaires de Geneve-HUG | Geneva | 1205 | Switzerland |
| UniversitatSspital Zurich | Zurich | 8091 | Switzerland |
| Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| St James's University Hospital | Leeds | LS9 7TF | United Kingdom |
| St.Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Royal Hallamshire HospitalSheffield Teaching Hospitals NHS Trust | Sheffield | S10 2JF | United Kingdom |
| The Royal Marsden Hospital | Sutton-Surrey | SM2 5PT | United Kingdom |
| The Royal Wolverhampton Hospital NHS Trust | Wolverhampton | WV10 0QP | United Kingdom |
| Result |
| Miguel JS, Weisel K, Moreau P, Lacy M, Song K, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Belch A, Palumbo A, Schey S, Sonneveld P, Yu X, Sternas L, Jacques C, Zaki M, Dimopoulos M. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Oct;14(11):1055-1066. doi: 10.1016/S1470-2045(13)70380-2. Epub 2013 Sep 3. |
| 27267105 | Derived | Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. doi: 10.1080/10428194.2016.1177181. Epub 2016 Jun 7. |
| 27081177 | Derived | Weisel KC, Dimopoulos MA, Moreau P, Lacy MQ, Song KW, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Knop S, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, San Miguel J. Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma. Haematologica. 2016 Jul;101(7):872-8. doi: 10.3324/haematol.2015.137083. Epub 2016 Apr 14. |
| 26250580 | Derived | Dimopoulos MA, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Spencer A, Knop S, Bahlis NJ, Renner C, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, San Miguel JF. Cytogenetics and long-term survival of patients with refractory or relapsed and refractory multiple myeloma treated with pomalidomide and low-dose dexamethasone. Haematologica. 2015 Oct;100(10):1327-33. doi: 10.3324/haematol.2014.117077. Epub 2015 Aug 6. |
| 26160879 | Derived | San Miguel JF, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Renner C, Bahlis NJ, Yu X, Teasdale T, Sternas L, Jacques C, Zaki MH, Dimopoulos MA. Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma. Haematologica. 2015 Oct;100(10):1334-9. doi: 10.3324/haematol.2015.125864. Epub 2015 Jul 9. |
| 26149712 | Derived | Weisel K, Dimopoulos M, Song KW, Moreau P, Palumbo A, Belch A, Schey S, Sonneveld P, Sternas L, Yu X, Amatya R, Gibson CJ, Zaki M, Jacques C, San Miguel J. Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial. Clin Lymphoma Myeloma Leuk. 2015 Sep;15(9):519-30. doi: 10.1016/j.clml.2015.05.007. Epub 2015 Jun 6. |
| 25425684 | Derived | Song KW, Dimopoulos MA, Weisel KC, Moreau P, Palumbo A, Belch A, Schey S, Sonneveld P, Sternas L, Yu X, Amatya R, Monzini MS, Zaki M, Jacques C, San Miguel J. Health-related quality of life from the MM-003 trial of pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed and/or refractory multiple myeloma. Haematologica. 2015 Feb;100(2):e63-7. doi: 10.3324/haematol.2014.112557. Epub 2014 Nov 25. No abstract available. |
| FG001 |
| High-Dose Dexamethasone (HD-Dex) |
Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression. |
| Received Study Drug |
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| Crossed-over to Pomalidomide |
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| COMPLETED | Completed represents participants who discontinued from study treatment |
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| NOT COMPLETED |
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| PFS Follow-up Phase |
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Intent-to-treat population (all participants who were randomized, regardless of whether they received study treatment or not)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pomalidomide Plus Low-Dose Dexamethasone | Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression. |
| BG001 | High-Dose Dexamethasone | Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Stratification Factor 1 | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Participants with Prior Anti-Myeloma (MM) Therapies | Count of Participants | Participants |
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| Time from First Pathologic Diagnosis | Mean | Standard Deviation | years |
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| Stratification Factor 2: Disease Population | Disease Population Group 1 is defined as refractory patients who have progressed on or within 60 days of both lenalidomide and bortezomib based treatments. Disease Population Group 2 is defined as relapsed and refractory patients who achieved at least a partial response (PR) and progressed within 6 months after stopping treatment with lenalidomide and/or bortezomib. Disease Population Group 3 is defined as refractory/intolerant patients who developed intolerance/toxicity after a minimum of 2 cycles of bortezomib. | Count of Participants | Participants |
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| Stratification Factor 3: Number of Prior Anti-MM Therapies | Count of Participants | Participants |
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| Multiple Myeloma Stage before Study Entry | The International Staging System divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels. Stage I: Serum beta-2 microglobulin is less than 3.5 (mg/L) and the albumin level is above 3.5 (g/L); Stage II: Neither stage I or III, meaning that either: ◾ The beta-2 microglobulin level is between 3.5 and 5.5 (with any albumin level), OR ◾ The albumin is below 3.5 while the beta-2 microglobulin is less than 3.5 Stage III: Serum beta-2 microglobulin is greater than 5.5. | 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 | Progression-free Survival (PFS) - Primary Analysis | Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease required 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. | Intent-to-treat population | Posted | Median | 95% Confidence Interval | weeks | From randomization until the data cut-off date of 07 September 2012. Maximum duration of follow-up for PFS assessments was 57 weeks. |
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| Primary | Progression-free Survival (PFS) With a Later Cut-off Date | Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease requires 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. | Intent-to-treat population | Posted | Median | 95% Confidence Interval | weeks | From randomization until the data cut-off date of 01 March 2013. Maximum duration of follow-up for PFS assessments was 74 weeks. |
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| Secondary | Number of Participants With Adverse Events (AEs) | An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death. | Safety population (all randomized participants who received at least one dose of study drug (either pomalidomide or dexamethasone)). | Posted | Count of Participants | Participants | From first dose of study drug through to 30 days after the last dose as of the end of the study (29 August 2017); maximum time on treatment was 297, 269, and 239 weeks in the Pomalidomide + LD-Dex, HD-Dex, and cross-over groups respectively. |
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| Secondary | Overall Survival - Primary Analysis | Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. | Intent-to-treat | Posted | Median | 95% Confidence Interval | weeks | From randomization until the data cut-off date of 07 September 2012. Maximum time on follow-up for survival was 70 weeks. |
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| Secondary | Overall Survival With a Later Cut-off Date | Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. | Intent-to-treat | Posted | Median | 95% Confidence Interval | weeks | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up for survival was 93 weeks. |
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| Secondary | Overall Survival Based on the Final Dataset | Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. | Intent-to-treat | Posted | Median | 95% Confidence Interval | weeks | From randomization until the data cut-off date of 29 August 2017. Maximum time on follow-up for survival was 324 weeks. |
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| Secondary | Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria | Objective response is defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on the Independent Response Adjudication Committee: SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. | Intent-to-treat population | Posted | Number | percentage of participants | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
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| Secondary | Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria | Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the Independent Response Adjudication Committee: CR requires all of the following: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions. | Intent-to-treat population | Posted | Number | percentage of participants | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
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| Secondary | Time to Progression | Time to progression (TTP) is calculated as the time from randomization to the first documented progression confirmed by a blinded, independent Response Adjudication Committee and based on the International Myeloma Working Group Uniform Response criteria (IMWG). Progressive disease requires 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. | Intent-to-treat population | Posted | Median | 95% Confidence Interval | weeks | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
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| Secondary | Time to Response | Time to response is calculated as the time from randomization to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required. | Intent-to-treat responder population | Posted | Median | Full Range | weeks | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
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| Secondary | Duration of Response | Duration of response (calculated for responders only) is defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria assessed by the Independent Response Adjudication Committee. | Intent-to-treat responder population | Posted | Median | 95% Confidence Interval | weeks | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
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| Secondary | Time to the First Hemoglobin Improvement | Time to increased hemoglobin, defined as the time from randomization to at least one category improvement from Baseline in common terminology criteria for adverse events (CTCAE) grade for hemoglobin level. Hemoglobin categories are: 1) Normal; 2) CTCAE Grade 1: < lower limit of normal (LLN) to 10.0 g/dL; 3) CTCAE Grade 2: < 10.0 to <8.0 g/dL. Participants with CTCAE Grade 3 anemia or worse at Baseline were excluded from the study. | Intent-to-treat population with improvement in hemoglobin during the study | Posted | Median | Full Range | weeks | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
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| Secondary | Time to Improvement in Bone Pain | Time to improvement in bone pain is defined as the time from randomization to at least one category improvement from Baseline in bone pain category. Bone pain was categorized (from best to worst) according to answers to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for patients with Multiple Myeloma Module (QLQ-MY20), Question 1, "Have you had bone aches or pain?": 1) Not at all, 2) A little, 3) Quite a bit, or 4) Very much. | Intent-to-treat population with improvement in bone pain | Posted | Median | Full Range | weeks | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
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| Secondary | Time to Improvement in Renal Function | Time to improvement in renal function is defined as the time from randomization to at least one category improvement from Baseline in renal function. Renal Function was categorized as (from best to worst): - Normal: creatinine clearance ≥80 mL/min; - Grade 1: creatinine clearance ≥60 to <80 mL/min; - Grade 2 : creatinine clearance ≥45 to < 60 mL/min. Participants with creatinine clearance < 45 mL/min at baseline were excluded from the study. | Intent-to-treat population with improvement in renal function | Posted | Median | Full Range | weeks | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
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| Secondary | Time to Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status | Time to improvement in ECOG performance status defined as the time from randomization until at least a one category improvement from Baseline in ECOG performance status score. The categories of the ECOG Performance Status Scale are as follows: -0: Fully active, able to carry on all pre-disease performance without restriction; -1: Restricted in physically strenuous activity but ambulatory and able to carry our work of a light or sedentary nature, e.g., light housework, office work; -2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. Patients with a score of 3, 4 or 5 were excluded from participating in the study. | Intent-to-treat population with improvement in ECOG performance status during the study | Posted | Median | Full Range | weeks | From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. |
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| Secondary | Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement. | The Patient Reported Outcomes (PRO) study population includes any intent-to-treat study participants with 1 active treatment and 1 PRO measurement item completed. Only participants with available data at Baseline and each time point are included. | Posted | Mean | Standard Deviation | units on a scale | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
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| Secondary | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | PRO population with available data at Baseline and each time point. | Posted | Mean | Standard Deviation | units on a scale | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
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| Secondary | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | PRO population with available data at Baseline and each time point. | Posted | Mean | Standard Deviation | units on a scale | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
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| Secondary | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom). | PRO population with available data at Baseline and each time point. | Posted | Mean | Standard Deviation | units on a scale | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
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| Secondary | Change From Baseline in the EORTC QLQ-C30 Pain Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reductions in pain (i.e. improvement in symptom) and positive values indicate increases in pain (i.e. worsening of symptom). | PRO population with available data at Baseline and each time point | Posted | Mean | Standard Deviation | units on a scale | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
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| Secondary | Change From Baseline in the European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms | The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective). The EORTC QLQ-MY20 Disease Symptoms Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction (i.e. improvement) in symptoms and positive values indicate increase (i.e. worsening) of symptoms. | PRO population with available data at Baseline and each time point. | Posted | Mean | Standard Deviation | units on a scale | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
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| Secondary | Change From Baseline in the EORTC QLQ-MY20 Side Effects Domain | The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective). The EORTC QLQ-MY20 Side Effects Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction in side effects (i.e.improvement in symptom) and positive values indicate increase in side effects (i.e. worsening of symptom). | PRO population with available data at Baseline and each time point. | Posted | Mean | Standard Deviation | units on a scale | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
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| Secondary | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Utility Index Score | EQ-5D is a self-administered questionnaire that assesses health-related quality of life (QOL). The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where an EQ-5D score of 1.00 equals "perfect health", a score of 0 equals "death" and a score of -0.59 equals worst imaginable health state. A positive change from Baseline score indicates improvement in health status. A negative change from Baseline score indicates worsening in health status. Negative scores represent the possible though unlikely situation that a patient's QOL is worse than death, i.e. they would rather be dead than living with that QOL | PRO population with available data at Baseline and each time point. | Posted | Mean | Standard Deviation | units on a scale | Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Worsening of Quality of Life (QOL) Domains | Time to worsening in quality of life domains was calculated as the time from Baseline to the first worsened minimally important difference (MID), defined as the smallest change in a QOL score considered important to patients that would lead the patient or clinician to consider a change in therapy. MID thresholds were calculated in Standard Error of Measurement (SEM) units using the Baseline QOL data. Based on the MID, participants were classified as worsened according to the following: For the EORTC QLQ-C30 global health status and functional scales and the EQ-5D health utility score, participants were classified as worsened if their change from Baseline score was less than -1 SEM. For the EORTC QLQ-C30 symptom scores (fatigue and pain) and EORTC QLQ-MY20 disease symptoms and side effects scales, participants were classified as worsened if their change from Baseline score was greater than 1 SEM. See previous outcome measures for definitions of each scale. | PRO population | Posted | Median | 95% Confidence Interval | days | Assessed on Day 1 of the first 6 treatment cycles. |
|
From first dose of study drug through to 30 days after the last dose as of the end of the study (29 August 2017); maximum time on treatment was 297, 269, and 239 weeks in the Pomalidomide + LD-Dex, HD-Dex, and cross-over groups respectively.
Not provided
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 | Pomalidomide Plus Low-Dose Dexamethasone | Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression. | 252 | 300 | 195 | 300 | 291 | 300 |
| EG001 | High-Dose Dexamethasone | Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression, or until cross-over to pomalidomide. Data are up to the time of cross-over. | 124 | 150 | 80 | 150 | 143 | 150 |
| EG002 | HD-Dex / Pomalidomide | Participants initially randomized to high-dose dexamethasone (HD-Dex) crossed over to receive 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle, with or without low-dose dexamethasone (40 mg for participants ≤ 75 years or 20 mg for participants > 75 years of age, administered orally once per day on Days 1, 8, 15, and 22 of each 28-day cycle) at the discretion of the investigator. Data include AEs that occurred after cross-over to pomalidomide. | 8 | 11 | 4 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19 | Systematic Assessment |
| |
| Blood disorder | Blood and lymphatic system disorders | MedDRA 19 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 19 | Systematic Assessment |
| |
| Hyperviscosity syndrome | Blood and lymphatic system disorders | MedDRA 19 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 19 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Cardiac amyloidosis | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA 19 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 19 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 19 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Necrotising colitis | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Papilla of Vater stenosis | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 19 | Systematic Assessment |
| |
| Gallbladder perforation | Hepatobiliary disorders | MedDRA 19 | Systematic Assessment |
| |
| Hepatic mass | Hepatobiliary disorders | MedDRA 19 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Bacterial diarrhoea | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Listeria sepsis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Meningitis cryptococcal | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Ophthalmic herpes simplex | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pneumococcal bacteraemia | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Salmonella sepsis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Septic arthritis streptococcal | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Spinal cord infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Subdural empyema | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 19 | Systematic Assessment |
| |
| Blood immunoglobulin M increased | Investigations | MedDRA 19 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 19 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 19 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Plasma cell leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Prostate cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Dyspraxia | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Vertigo CNS origin | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 19 | Systematic Assessment |
| |
| Bradyphrenia | Psychiatric disorders | MedDRA 19 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 19 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 19 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19 | Systematic Assessment |
| |
| Crush syndrome | Renal and urinary disorders | MedDRA 19 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 19 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 19 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 19 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA 19 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 19 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 19 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 19 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 19 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 19 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 19 | Systematic Assessment |
| |
| Macular pigmentation | Eye disorders | MedDRA 19 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Parotid gland enlargement | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Chillblains | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 19 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 19 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 19 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 19 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 19 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 19 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 19 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 19 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 19 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 19 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 19 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 19 | Systematic Assessment |
|
Institution may publish the results of its findings if a multicenter publication is not forthcoming within 18 months after study completion. Institution shall provide Celgene with a copy of the papers prior to submission; Celgene shall complete its review within 60 days after receipt. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of patentable material.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials Disclosure | Celgene Corporation | 1-888-260-1599 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| > 75 Years Old |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| White |
|
| Other |
|
| Not collected |
|
| Disease Population Group 2 |
|
| Disease Population Group 3 |
|
| > 2 Prior Anti-MM Therapies |
|
| Stage II |
|
| Stage III |
|
| Missing |
|
|
|
|
| OG001 | High-Dose Dexamethasone | Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression, or until cross-over to pomalidomide. Data are up to the time of cross-over. |
| OG002 | HD-Dex / Pomalidomide | Participants initially randomized to high-dose dexamethasone (HD-Dex) crossed over to receive 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle, with or without low-dose dexamethasone (40 mg for participants ≤ 75 years or 20 mg for participants > 75 years of age, administered orally once per day on Days 1, 8, 15, and 22 of each 28-day cycle) at the discretion of the investigator. Data include AEs that occurred after cross-over to pomalidomide. |
|
|
| Participants |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression. |
|
|
|
| OG001 | High-Dose Dexamethasone | Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression. |
|
|
|
|
|
|
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| OG001 | High-Dose Dexamethasone | Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 |
| High-Dose Dexamethasone |
Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression. |
|
|
Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression. |
|
|