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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC 26071-22072 | |||
| 2007-004344-78 | EudraCT Number |
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| Name | Class |
|---|---|
| European Organisation for Research and Treatment of Cancer - EORTC | NETWORK |
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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CENTRIC is a Phase 3 clinical trial assessing efficacy and safety of the investigational integrin inhibitor, cilengitide, in combination with standard treatment versus standard treatment alone in newly diagnosed glioblastoma subjects with a methylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue.
The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to be a predictive marker for benefit from temozolomide (TMZ) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilengitide + Temozolomide + Radiotherapy | Experimental |
| |
| Temozolomide + Radiotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilengitide | Drug | Cilengitide 2000 milligram (mg) will be administered intravenously twice weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Time | The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. | Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Time - Investigator and Independent Read | The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site and Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC). Investigator's assessed progression according to MacDonald criteria and IRC by Response Assessment in Neuro-Oncology Working Group (RANO) criteria using Gadolinium-enhanced magnetic resonance imaging. Investigator and IRC read: Progression is defined as greater than 25 percent increase in the sum of the product of the largest perpendicular diameters of enhancing tumor compared to the smallest prior sum, or Worsening of an evaluable lesion(s),or Marked increase in T2/FLAIR non-enhancing lesions (IRC only) or Any new lesion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Stupp, Prof. Dr. | University of Lausanne Medical Center (CHUV) | Study Chair |
| Andriy Markivskyy, MD | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please Contact U.S. Medical Information Located in | Rockland | Massachusetts | United States | |||
| Please Contact the Merck KGaA Communication Center Located in |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Cilengitide combined with standard treatment for patients with newly diagnosed glioblastoma with methylated MGMT promoter (CENTRIC EORTC 26071-22072 study): a multicentre, randomised, open-label, phase 3 trial Roger Stupp, Monika E Hegi, Thierry Gorlia, Sara C Erridge, James Perry, Yong-Kil Hong, Kenneth D Aldape, Benoit Lhermitte, Torsten Pietsch, Danica Grujicic, Joachim Peter Steinbach, Wolfgang Wick, Rafał Tarnawski, Do-Hyun Nam, Peter Hau, Astrid Weyerbrock, Martin J B Taphoorn, Chiung-Chyi Shen, Nalini Rao, László Thurzo, Ulrich Herrlinger, Tejpal Gupta, Rolf-Dieter Kortmann, Krystyna Adamska, Catherine McBain, Alba A Brandes, Joerg Christian Tonn, Oliver Schnell, Thomas Wiegel, Chae-Yong Kim, Louis Burt Nabors, David A Reardon, Martin J van den Bent, Christine Hicking, Andriy Markivskyy, Martin Picard, Michael Weller The Lancet Oncology 20 August 2014(Article in Press DOI: 10.1016/S1470-2045(14)70379-1) | ||
| 36346112 | Derived | Seliger C, Oppong FB, Lefranc F, Chinot O, Stupp R, Nabors B, Gorlia T, Weller M; EORTC Brain Tumor Group. Association of antidepressant drug use with outcome of patients with glioblastoma. Int J Cancer. 2023 Apr 1;152(7):1348-1359. doi: 10.1002/ijc.34344. Epub 2022 Nov 17. | |
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Enrolled: 3471 screened for eligibility; 2926 excluded (mainly due to unmethylated O6-methylguanine-DNA methyltransferase status and non-fulfillment of inclusion or exclusion criteria), 545 participants randomized.
First/last participant (informed consent): Sep 2008/Aug 2011. Clinical data cut-off: 19 Nov 2012, Study completion date: Aug 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cilengitide + Temozolomide + Radiotherapy | Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Temozolomide | Drug | Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] will be administered intravenously once daily from Weeks 1 to 6. From Week 11 onwards, TMZ will be given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 or until disease progression. |
|
| Radiotherapy | Radiation | Radiotherapy (RTX) at a dose of 2 gray (Gy) per fraction will be given once daily, 5 days per week from Weeks 1 to 6, total dose 60 Gy. |
|
| Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012) |
| Maximum Observed Plasma Concentration (Cmax) | The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1. | Day 1 of Week -1 |
| Time to Maximum Plasma Concentration (Tmax) | The Tmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1. | Day 1 of Week -1 |
| Area Under the Plasma Concentration Curve From Time 0 to 6 Hours (AUC [0-6]) After Dose | The AUC (0-6) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1. | Day 1 of Week -1 |
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Sub-scale Scores | The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale. | Up to 50 months |
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Brain Module (EORTC QLQ-BN20) Sub-scale Scores | The QLQ-BN20 is a questionnaire specifically designed as the QLQ-C30 supplement for the evaluation of quality of life in brain tumor participants. It includes 4 multi-item sub-scales: future uncertainty, visual disorder, motor dysfunction, communication deficits, and 7 single-item scales: headaches, seizures, drowsiness, itchy skin, hair loss, weakness of legs, and bladder control. All items are rated on a 4-point Likert-type scale ('1=not at all', '2=a little', '3=quite a bit' and '4=very much'), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms. | Up to 50 months |
| EuroQol 5-Dimensions (EQ-5D) Questionnaire Index | The EuroQuol-5D (EQ-5D) questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.594 (death) and the highest is 1.00 (full health). | Up to 50 months |
| Number of Participants With Change From Baseline in Work Status at End of Study | Number of participants with change from baseline in work status (working full time [FT], part-time [PT], unemployed/retired [U/R]) at end of study (EOS) (up to cut-off date, [19 Nov 2012]) was reported. For the category 'part-time', the following sub-categories were defined: part-time due to basic disease (PT1); part-time not due to basic disease (PT2); part-time reason not known (PT3). | Baseline, End of study (up to cut-off date, [19 Nov 2012]) |
| Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment Related AEs of Grade 3 or 4 | An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome. | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012) |
| Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI-CTC Toxicity Grade 3 or 4 | Thromboembolic events (standardized MedDRA query [SMQ]) Grade 3 or 4 AEs encompassed hemiparesis and cerebrovascular accident, pulmonary embolism, and deep vein thrombosis. Thromboembolic events (SMQ) of any grade and of Grade 3 or 4 were generally more frequent in the Cilengitide + Temozolomide/Radiotherapy group than in the Temozolomide/Radiotherapy group but were still in the expected range of this patient population The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome. | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012) |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters | Up to 50 months |
| Darmstadt |
| Germany |
| 25163906 |
| Derived |
| Stupp R, Hegi ME, Gorlia T, Erridge SC, Perry J, Hong YK, Aldape KD, Lhermitte B, Pietsch T, Grujicic D, Steinbach JP, Wick W, Tarnawski R, Nam DH, Hau P, Weyerbrock A, Taphoorn MJ, Shen CC, Rao N, Thurzo L, Herrlinger U, Gupta T, Kortmann RD, Adamska K, McBain C, Brandes AA, Tonn JC, Schnell O, Wiegel T, Kim CY, Nabors LB, Reardon DA, van den Bent MJ, Hicking C, Markivskyy A, Picard M, Weller M; European Organisation for Research and Treatment of Cancer (EORTC); Canadian Brain Tumor Consortium; CENTRIC study team. Cilengitide combined with standard treatment for patients with newly diagnosed glioblastoma with methylated MGMT promoter (CENTRIC EORTC 26071-22072 study): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Sep;15(10):1100-8. doi: 10.1016/S1470-2045(14)70379-1. Epub 2014 Aug 19. |
| FG001 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
| COMPLETED |
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| NOT COMPLETED |
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|
Intent-to-treat (ITT) population included all the participants who were randomized to study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cilengitide + Temozolomide + Radiotherapy | Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator. |
| BG001 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) Time | The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. | ITT population included all the participants who were randomized to study treatment. | Posted | Median | 95% Confidence Interval | Months | Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012) |
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| Secondary | Progression Free Survival (PFS) Time - Investigator and Independent Read | The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site and Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC). Investigator's assessed progression according to MacDonald criteria and IRC by Response Assessment in Neuro-Oncology Working Group (RANO) criteria using Gadolinium-enhanced magnetic resonance imaging. Investigator and IRC read: Progression is defined as greater than 25 percent increase in the sum of the product of the largest perpendicular diameters of enhancing tumor compared to the smallest prior sum, or Worsening of an evaluable lesion(s),or Marked increase in T2/FLAIR non-enhancing lesions (IRC only) or Any new lesion | ITT population included all the participants who were randomized to study treatment. | Posted | Median | 95% Confidence Interval | Months | Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) | The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1. | Analysis population included all participants of "Cilengitide + Temozolomide + Radiotherapy" group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1 of Week -1 |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) | The Tmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1. | Analysis population included all participants of "Cilengitide + Temozolomide + Radiotherapy" group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1. | Posted | Mean | Standard Deviation | hours | Day 1 of Week -1 |
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| Secondary | Area Under the Plasma Concentration Curve From Time 0 to 6 Hours (AUC [0-6]) After Dose | The AUC (0-6) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1. | Analysis population included all participants of "Cilengitide + Temozolomide + Radiotherapy" group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hour*ng/mL | Day 1 of Week -1 |
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| Secondary | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Sub-scale Scores | The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale. | ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category. | Posted | Mean | Standard Deviation | units on a scale | Up to 50 months |
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| Secondary | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Brain Module (EORTC QLQ-BN20) Sub-scale Scores | The QLQ-BN20 is a questionnaire specifically designed as the QLQ-C30 supplement for the evaluation of quality of life in brain tumor participants. It includes 4 multi-item sub-scales: future uncertainty, visual disorder, motor dysfunction, communication deficits, and 7 single-item scales: headaches, seizures, drowsiness, itchy skin, hair loss, weakness of legs, and bladder control. All items are rated on a 4-point Likert-type scale ('1=not at all', '2=a little', '3=quite a bit' and '4=very much'), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms. | ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category. | Posted | Mean | Standard Deviation | units on a scale | Up to 50 months |
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| Secondary | EuroQol 5-Dimensions (EQ-5D) Questionnaire Index | The EuroQuol-5D (EQ-5D) questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.594 (death) and the highest is 1.00 (full health). | ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Up to 50 months |
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| Secondary | Number of Participants With Change From Baseline in Work Status at End of Study | Number of participants with change from baseline in work status (working full time [FT], part-time [PT], unemployed/retired [U/R]) at end of study (EOS) (up to cut-off date, [19 Nov 2012]) was reported. For the category 'part-time', the following sub-categories were defined: part-time due to basic disease (PT1); part-time not due to basic disease (PT2); part-time reason not known (PT3). | Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period. | Posted | Number | participants | Baseline, End of study (up to cut-off date, [19 Nov 2012]) |
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| Secondary | Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment Related AEs of Grade 3 or 4 | An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome. | Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period. | Posted | Number | Participants | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012) |
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| Secondary | Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI-CTC Toxicity Grade 3 or 4 | Thromboembolic events (standardized MedDRA query [SMQ]) Grade 3 or 4 AEs encompassed hemiparesis and cerebrovascular accident, pulmonary embolism, and deep vein thrombosis. Thromboembolic events (SMQ) of any grade and of Grade 3 or 4 were generally more frequent in the Cilengitide + Temozolomide/Radiotherapy group than in the Temozolomide/Radiotherapy group but were still in the expected range of this patient population The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome. | Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period. | Posted | Number | Participants | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012) |
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| Secondary | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters | Any clinically significant abnormal ECG and lab finding was planned to be reported as AE only so they have been captured in the below mentioned adverse event section. | Posted | Up to 50 months |
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Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012)
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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 | Cilengitide + Temozolomide + Radiotherapy | Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 will be optional in participants without disease progression, If cilengitide treatment considered beneficial in the opinion of the Investigator, | 138 | 263 | 251 | 263 | ||
| EG001 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. | 115 | 258 | 240 | 258 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONVULSION | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| GRAND MAL CONVULSION | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PARTIAL SEIZURES | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| STATUS EPILEPTICUS | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| COGNITIVE DISORDER | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ATAXIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| INTRACRANIAL PRESSURE INCREASED | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| APHASIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| SPEECH DISORDER | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| BRAIN INJURY | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CENTRAL NERVOUS SYSTEM NECROSIS | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CEREBRAL CYST | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CEREBRAL VENTRICLE DILATATION | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| COMA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| COORDINATION ABNORMAL | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| FACIAL NERVE DISORDER | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYDROCEPHALUS | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEUROLOGICAL DECOMPENSATION | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NORMAL PRESSURE HYDROCEPHALUS | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| POST HERPETIC NEURALGIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PYRAMIDAL TRACT SYNDROME | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| TRIGEMINAL NEURALGIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| VIITH NERVE PARALYSIS | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| VISUAL FIELD DEFECT | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DISSEMINATED INTRAVASCULAR COAGULATION | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| FEBRILE BONE MARROW APLASIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HAEMATOTOXICITY | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| H1N1 INFLUENZA | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| NECROTISING FASCIITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| WOUND ABSCESS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| BACTERIAL INFECTION | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| BRAIN ABSCESS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| DEVICE RELATED SEPSIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| EPIGLOTTITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| MENINGITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| VOCAL CORD POLYP | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DEVICE MALFUNCTION | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PAIN | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| GASTRIC DISORDER | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PELVIC VENOUS THROMBOSIS | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| EMBOLISM VENOUS | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| SUBCLAVIAN VEIN THROMBOSIS | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| VENOUS THROMBOSIS | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DISORIENTATION | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DYSTHYMIC DISORDER | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HALLUCINATION, VISUAL | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PANIC ATTACK | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PERSONALITY CHANGE | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| SCHIZOPHRENIA | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| OPEN WOUND | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| POST PROCEDURAL OEDEMA | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| POSTOPERATIVE WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| RADIATION INJURY | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| RADIATION NECROSIS | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| BLOOD URIC ACID INCREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| FIBRIN D DIMER INCREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| GLIOBLASTOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| INTRACRANIAL TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| METASTASES TO MENINGES | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEOPLASM RECURRENCE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEURILEMMOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| SMALL CELL LUNG CANCER STAGE UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CORONARY ARTERY THROMBOSIS | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| BLADDER NECK OBSTRUCTION | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CALCULUS URINARY | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| EXFOLIATIVE RASH | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| BLADDER CATHETERISATION | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
| |
| PALLIATIVE CARE | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
| |
| SURGERY | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ADRENAL INSUFFICIENCY | Endocrine disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION | Endocrine disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| APHASIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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All manuscripts and materials relating to Study shall be submitted to Sponsor at least 60 days prior to submitting/presenting and allow Sponsor 60 days for review. If Sponsor requests, any confidential information shall be removed. In multi-center study, any publication shall not be made before the first multi-center publication; provided, however, that if no multi-center publication is made within 1 year from database lock, then Site may publish individually in accordance with this provision.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C422910 | Cilengitide |
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
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| OG001 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
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| Participants |
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| OG001 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
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| OG001 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
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| OG001 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
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| OG001 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
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Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator. |
| OG001 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
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| OG001 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
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