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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-009836-54 | EudraCT Number |
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The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomide 5 mg | Experimental | Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug |
|
| Lenalidomide 10 mg | Experimental | Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug |
|
| Lenalidomide 15 mg | Experimental | Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lenalidomide | Drug | Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Adverse events (AEs) were graded for severity by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 with the exceptions of hematologic toxicities and tumor lysis syndrome, according to the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening or disabling AE Grade 5 = Death The investigator determined the relationship of each AE to study drug based on the timing of the AE and whether other medications, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the observed event. | From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR was defined as the percentage of patients with a complete response (CR), CR with incomplete bone marrow (BM) recovery (CRi) or partial response (PR) during treatment. Response was assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines. Per the guidelines, a CR required peripheral blood lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, no hepatomegaly or splenomegaly, absence of disease and blood counts neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin (hgb) >11g/dL) and BM at least normocellular for age. CRi = CR with incomplete BM recovery. PR = required at least 2 months from end of treatment, a ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value and either a ≥ 50% reduction in lymphadenopathy or ≥50% reduction of liver enlargement or ≥50% reduction of spleen enlargement plus neutrophils >1.5 x 10^9/ or ≥50% increase, platelets >100 x 10^9/L or ≥50% increase, hgb 11 g/dL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery Jones, M.D., MPH | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Moores Cancer Center | La Jolla | California | 92093-0820 | United States | ||
| Desert Hematology Oncology Medical Group, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26763349 | Background | Wendtner CM, Hallek M, Fraser GA, Michallet AS, Hillmen P, Durig J, Kalaycio M, Gribben JG, Stilgenbauer S, Buhler A, Kipps TJ, Purse B, Zhang J, De Bedout S, Mei J, Chanan-Khan A. Safety and efficacy of different lenalidomide starting doses in patients with relapsed or refractory chronic lymphocytic leukemia: results of an international multicenter double-blinded randomized phase II trial. Leuk Lymphoma. 2016;57(6):1291-9. doi: 10.3109/10428194.2015.1128540. Epub 2016 Jan 14. | |
| 26967821 |
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Participants were randomized (1:1:1) in a double-blind fashion, according to age (< 65 versus ≥ 65 years) and disease status (relapsed versus refractory) to their last purine-analog or bendamustine-based prior regimen.
Participants were randomized at 29 sites from North America and Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lenalidomide 5 mg | Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2015 | Aug 31, 2018 |
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|
| Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months. |
| Kaplan-Meier Estimate of Duration of Response | Duration of response (DOR) was defined as the time from the first visit where PR, CRi, or CR was documented to progressive disease (PD). Duration of response was censored at the last date that the participant was known to be progression-free for participants who had not progressed at the time of analysis or who withdrew consent or were lost to follow-up prior to documentation of progression. | Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months. |
| Time to Response | Time to response (TTR) was calculated as the time from randomization to the first documented date of response (PR, CRi or CR) based on iwCLL guidelines for participants with an objective response during the treatment period. | Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months. |
| Kaplan-Meier Estimate of Time to Progression | Time to progression (TTP) was defined as the time from randomization to the first documented progression. For participants who did not progress during the study, TTP was censored at the last adequate response assessment showing evidence of no disease progression. | From randomization until the end of the study; maximum time on study was 91 months. |
| Kaplan-Meier Estimate of Event-Free Survival | Event-free survival (EFS) is the interval between the start of treatment to the first sign of disease progression, or treatment for relapse or death (whichever occurred first). If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression. | From randomization until the end of the study; maximum time on study was 91 months. |
| Kaplan-Meier Estimate of Progression Free Survival | Progression-free survival (PFS) was calculated as the time from randomization to the first documented progression or death due to any cause during or after the treatment period, whichever occurred first. The progression date was assigned to the earliest time when any progression is observed without prior missing assessments. If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression. | From randomization until the end of the study; maximum time on study was 91 months. |
| Kaplan-Meier Estimate of Overall Survival | Overall survival (OS) was defined 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 had withdrawn consent or were lost to follow-up before death was documented. | From randomization until the end of the study; maximum time on study was 91 months. |
| Rancho Mirage |
| California |
| 92270 |
| United States |
| Stanford University School of Medicine | Stanford | California | 94305-5821 | United States |
| Cancer Center of Central Connecticut | Southington | Connecticut | 06489 | United States |
| Cancer and Blood Disease Center | Lecanto | Florida | 34461 | United States |
| Northwestern University Medical Center Division of Hematology Oncology | Chicago | Illinois | 60611-2927 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5149 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Long Island Jewish Medical Center CLL Research and Treatment Program | New Hyde Park | New York | 11042 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27104 | United States |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Drexel University, College of Medicine, Clinical Research Group | Philadelphia | Pennsylvania | 19102 | United States |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| CHU Sud | Amiens | 80054 | France |
| Hopital Avicenne | Bobigny | 93009 | France |
| CHU Grenoble | Grenoble | 38043 | France |
| Clinique Victor Hugo | Le Mans | 72000 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| CHU Montpellier - Hôpital Saint Eloi | Montpellier | 34295 | France |
| Hopital Emile Muller | Mulhouse | 68000 | France |
| Hopital Pitie Salpetriere | Paris | 75651 | France |
| CH Perpignan - Hopital Saint-Jean | Perpignan | 66046 | France |
| CHRU - Hopital du Haut Leveque | Pessac | 33604 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| Hopital Robert Debre | Reims | 51092 | France |
| CHU Rennes Hematology | Rennes | 35033 | France |
| CHRU Hopital Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Charite -Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| Klinikum der Universitat zu Koln | Cologne | 50924 | Germany |
| Universitatsklinikum Essen | Essen | 45122 | Germany |
| Ernst-Moritz-Arndt-Universität Greifswald | Greifswald | 17487 | Germany |
| Universitatsklinikum Schleswig Holstein | Kiel | 24116 | Germany |
| University of Ulm Abteilung Innere Medizin III | Ulm | 89081 | Germany |
| Azienda Ospedaliera Universitaria San Martino | Genova | 16132 | Italy |
| Ematologia ed Immunologia, Azienda Ospedaliera "Vito Fazzi" di Lecce | Lecce | 73100 | Italy |
| I.R.C.C.S. Ospedale San Raffaele | Milan | 20132 | Italy |
| Istituto Europeo di Oncologia - IEO | Milan | 20141 | Italy |
| Universita degli Studi di Padova | Padova | 35128 | Italy |
| Universita' Degli Studi Di Perugia | Perugia | 06100 | Italy |
| Hospital Clinic Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitari Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Karolinska Universitetssjukhuset | Stockholm | 14186 | Sweden |
| St James's Institute of Oncology | Leeds | LS9 7TF | United Kingdom |
| St.Bartholomew's Hospital | London | EC1M 6BQ | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| The Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Christie Hospital NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Background |
| Buhler A, Wendtner CM, Kipps TJ, Rassenti L, Fraser GA, Michallet AS, Hillmen P, Durig J, Gregory SA, Kalaycio M, Aurran-Schleinitz T, Trentin L, Gribben JG, Chanan-Khan A, Purse B, Zhang J, De Bedout S, Mei J, Hallek M, Stilgenbauer S. Lenalidomide treatment and prognostic markers in relapsed or refractory chronic lymphocytic leukemia: data from the prospective, multicenter phase-II CLL-009 trial. Blood Cancer J. 2016 Mar 11;6(3):e404. doi: 10.1038/bcj.2016.9. |
| FG001 | Lenalidomide 10 mg | Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug. |
| FG002 | Lenalidomide 15 mg | Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug. |
| Received Treatment |
|
| COMPLETED | completed represents participants who discontinued the study. |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lenalidomide 5 mg | Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. |
| BG001 | Lenalidomide 10 mg | Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. |
| BG002 | Lenalidomide 15 mg | Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events | Adverse events (AEs) were graded for severity by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 with the exceptions of hematologic toxicities and tumor lysis syndrome, according to the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening or disabling AE Grade 5 = Death The investigator determined the relationship of each AE to study drug based on the timing of the AE and whether other medications, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the observed event. | Randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively. |
|
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| Secondary | Overall Response Rate (ORR) | ORR was defined as the percentage of patients with a complete response (CR), CR with incomplete bone marrow (BM) recovery (CRi) or partial response (PR) during treatment. Response was assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines. Per the guidelines, a CR required peripheral blood lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, no hepatomegaly or splenomegaly, absence of disease and blood counts neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin (hgb) >11g/dL) and BM at least normocellular for age. CRi = CR with incomplete BM recovery. PR = required at least 2 months from end of treatment, a ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value and either a ≥ 50% reduction in lymphadenopathy or ≥50% reduction of liver enlargement or ≥50% reduction of spleen enlargement plus neutrophils >1.5 x 10^9/ or ≥50% increase, platelets >100 x 10^9/L or ≥50% increase, hgb 11 g/dL. | All randomized participants (intent-to-treat population) | Posted | Number | percentage of participants | Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Duration of Response | Duration of response (DOR) was defined as the time from the first visit where PR, CRi, or CR was documented to progressive disease (PD). Duration of response was censored at the last date that the participant was known to be progression-free for participants who had not progressed at the time of analysis or who withdrew consent or were lost to follow-up prior to documentation of progression. | Randomized participants with an objective response (CR/CRi or PR) | Posted | Median | 95% Confidence Interval | weeks | Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months. |
| |||||||||||||||||||||||||||||||||||
| Secondary | Time to Response | Time to response (TTR) was calculated as the time from randomization to the first documented date of response (PR, CRi or CR) based on iwCLL guidelines for participants with an objective response during the treatment period. | Randomized participants with an objective response (CR/CRi or PR) | Posted | Median | Full Range | weeks | Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months. |
| |||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Time to Progression | Time to progression (TTP) was defined as the time from randomization to the first documented progression. For participants who did not progress during the study, TTP was censored at the last adequate response assessment showing evidence of no disease progression. | All randomized participants | Posted | Median | 95% Confidence Interval | weeks | From randomization until the end of the study; maximum time on study was 91 months. |
| |||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Event-Free Survival | Event-free survival (EFS) is the interval between the start of treatment to the first sign of disease progression, or treatment for relapse or death (whichever occurred first). If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression. | All randomized participants | Posted | Median | 95% Confidence Interval | weeks | From randomization until the end of the study; maximum time on study was 91 months. |
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| Secondary | Kaplan-Meier Estimate of Progression Free Survival | Progression-free survival (PFS) was calculated as the time from randomization to the first documented progression or death due to any cause during or after the treatment period, whichever occurred first. The progression date was assigned to the earliest time when any progression is observed without prior missing assessments. If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression. | All randomized participants | Posted | Median | 95% Confidence Interval | weeks | From randomization until the end of the study; maximum time on study was 91 months. |
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| Secondary | Kaplan-Meier Estimate of Overall Survival | Overall survival (OS) was defined 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 had withdrawn consent or were lost to follow-up before death was documented. | All randomized participants | Posted | Median | 95% Confidence Interval | weeks | From randomization until the end of the study; maximum time on study was 91 months. |
|
From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lenalidomide 5 mg | Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug. | 24 | 34 | 24 | 34 | 34 | 34 |
| EG001 | Lenalidomide 10 mg | Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug. | 23 | 34 | 24 | 34 | 34 | 34 |
| EG002 | Lenalidomide 15 mg | Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug. | 26 | 35 | 27 | 35 | 35 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AGRANULOCYTOSIS | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| FEBRILE BONE MARROW APLASIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| IMMUNE THROMBOCYTOPENIC PURPURA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| LYMPHADENITIS | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| SPLENIC INFARCTION | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| IMPAIRED HEALING | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ASPERGILLUS INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| ATYPICAL PNEUMONIA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| EPIDIDYMITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| EPIGLOTTITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| ESCHERICHIA BACTERAEMIA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| ESCHERICHIA SEPSIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| GASTROENTERITIS SALMONELLA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| INFECTIOUS MONONUCLEOSIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| NEUTROPENIC INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| OESOPHAGEAL CANDIDIASIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| PNEUMONIA INFLUENZAL | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| POST PROCEDURAL CELLULITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| SALMONELLOSIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| SYSTEMIC MYCOSIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| TUBERCULOSIS OF PERIPHERAL LYMPH NODES | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| ALCOHOL POISONING | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ARTHRITIS REACTIVE | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| COCCYDYNIA | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ACUTE LYMPHOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| ADENOCARCINOMA PANCREAS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| ANAL SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| BOWEN'S DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| KERATOACANTHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| MALIGNANT PLEURAL EFFUSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| MENINGIOMA BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| METASTATIC SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| NEUROFIBROMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| OLIGOASTROCYTOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| TUMOUR FLARE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| LUNG CONSOLIDATION | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ACTINIC KERATOSIS | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| EXFOLIATIVE RASH | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| SUBCUTANEOUS EMPHYSEMA | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| VENOUS THROMBOSIS LIMB | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| AUTOIMMUNE HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| LYMPH NODE PAIN | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ORAL PAIN | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| LOCAL SWELLING | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPOGAMMAGLOBULINAEMIA | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| HERPES SIMPLEX | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| LABYRINTHITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| SALMONELLOSIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| BLOOD IMMUNOGLOBULIN G DECREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| BLOOD PHOSPHORUS DECREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| TUMOUR FLARE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| NASAL DRYNESS | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| EXFOLIATIVE RASH | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| RASH MACULAR | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| SWELLING FACE | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| URTICARIA PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials Disclosure | Celgene Corporation | 1-888-260-1599 | ClinicalTrialDisclosure@Celgene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2012 | Aug 31, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| ≥ 65 years |
|
| Male |
|
| Black or African American |
|
| Other |
|
| Unknown |
|
|
| Grade 3/4 adverse events |
|
| Treatment-related Grade 3/4 adverse events |
|
| Grade 5 adverse events |
|
| Treatment-related Grade 5 adverse events |
|
| Serious adverse events |
|
| Treatment-related serious adverse events |
|
| AE leading to discontinuation of study drug |
|
| TRAE leading to discontinuation of study drug |
|
| AE leading to study drug dose reduction only |
|
| AE leading to study drug dose interruption only |
|
| AE leading to study drug interruption & reduction |
|
Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. |
| OG002 | Lenalidomide 15 mg | Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. |
|
|
Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
|
|
|
|
|
|
|
|
Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. |
|
|
|
|