Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007008-27 |
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This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is <500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2A | Experimental |
| |
| Part 2B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab [Avastin] | Drug | 7.5mg/kg iv on day 1 of each 3-week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival During Maintenance Treatment Phase | Progression free survival (PFS) is defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) , or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Progression is defined using (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter. | Up to 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival During Maintenance Treatment Phase | Overall survival (OS) is assessed from the date of first induction treatment until the date of death. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter. | Up to 21 months |
| Best Overall Response Rate During Maintenance Treatment Phase |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Béziers | 34500 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23835708 | Derived | Barlesi F, Scherpereel A, Rittmeyer A, Pazzola A, Ferrer Tur N, Kim JH, Ahn MJ, Aerts JG, Gorbunova V, Vikstrom A, Wong EK, Perez-Moreno P, Mitchell L, Groen HJ. Randomized phase III trial of maintenance bevacizumab with or without pemetrexed after first-line induction with bevacizumab, cisplatin, and pemetrexed in advanced nonsquamous non-small-cell lung cancer: AVAPERL (MO22089). J Clin Oncol. 2013 Aug 20;31(24):3004-11. doi: 10.1200/JCO.2012.42.3749. Epub 2013 Jul 8. |
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Of the 376 participants enrolled in this study, 3 participants did not start induction phase treatment.
A total of 414 participants were screened out of which 38 participants were excluded for not meeting the eligibility criteria, declining to participate, or for other reasons. A total of 376 participants were recruited over an 18-month period across 81 centers in 11 countries from 17 August 2009 to 3 May 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Induction Treatment Phase | Bevacizumab 7.5 milligram (mg)/ kilogram (kg) + cisplatin 75 mg/m^2 + pemetrexed 500 mg/m^2 was administered intravenously (IV) every 3 weeks. Participants received 4 cycles of induction therapy. |
| FG001 | Bevacizumab Maintenance Treatment (Trt) Arm A |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Treatment Phase |
|
Not provided
Not provided
Not provided
Not provided
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| cisplatin | Drug | 75mg/m2 iv on day 1 of each 3-week cycle |
|
| pemetrexed | Drug | 500mg/m2 iv on day 1 of each 3-week cycle |
|
The best overall response rate (BORR) is defined as the percentage of participants having achieved confirmed Complete Response (CR) and Partial Response (PR) as the best overall response. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a greater than or equal to (≥) 30% decrease under baseline of the sum of diameters of all target lesions. Stable disease (SD) is defined as steady state of disease with neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter. |
| Up to 21 months |
| Duration of Response During Maintenance Treatment Phase | Duration of response is defined as the time in months from the initial start of response PR or better to the earlier of documented PD or death due to any cause. Participants who had neither progressed nor died at the date of clinical cutoff, who withdrew from the study, were lost to follow-up, or were without documented disease progression were censored at the date of the last available tumor assessment. The analysis was based on all participants with measurable disease at baseline who achieved response.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter. | Up to 21 months |
| Duration of Disease Control During Maintenance Treatment Phase | Duration of disease control is defined as the time in months from randomization to the earlier of documented PD or death due to any cause. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter. | Up to 21 months |
| Incidence of Adverse Events and Serious Adverse Event | An adverse events (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution. | Up to 21 months |
| Number of Participants With Marked Laboratory Abnormalities | Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from Baseline. The reference range for Platelets was 100-550 (10^9/L), for White blood cells (WBC) was 3.0-18.0 (10^9/L), for Lymphocytes was 0.70-7.60 (10^9/L), and Neutrophil 1.50-9.25 (10^9/L ). | Up to 21 months |
| Quality of Life | European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Cancer 30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Lung Cancer 13 [EORTC QLQ-LC13]consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. QOL was assessed using Pre-Induction Baseline (Pre-ind BL), Maintenance (MTC), End of study (EOS) cycles. | Up to 21 months |
| Bordeaux |
| 33077 |
| France |
| Bron | 69677 | France |
| Caen | 14033 | France |
| Caen | 14076 | France |
| Clermont-Ferrand | 63003 | France |
| Créteil | 94010 | France |
| Gap | 05007 | France |
| Gleizé | 69400 | France |
| La Source | 45100 | France |
| La Tronche | 38700 | France |
| Lille | 59037 | France |
| Limoges | 87039 | France |
| Lyon | 69317 | France |
| Marseille | 13915 | France |
| Nancy | 54100 | France |
| Nîmes | 30900 | France |
| Paris | 75571 | France |
| Paris | 75674 | France |
| Paris | 75970 | France |
| Perpignan | 66046 | France |
| Pierre-Bénite | 69495 | France |
| Reims | 51092 | France |
| Saint-Priest-en-Jarez | 42770 | France |
| Strasbourg | 67065 | France |
| Toulon | 83041 | France |
| Tours | 37044 | France |
| Augsburg | 86150 | Germany |
| Bad Berka | 99437 | Germany |
| Berlin | 13125 | Germany |
| Bonn | 53113 | Germany |
| Ebensfeld | 96250 | Germany |
| Frankfurt | 60488 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Gauting | 82131 | Germany |
| Großhansdorf | 22927 | Germany |
| Halle | 06120 | Germany |
| Hamburg | 21075 | Germany |
| Immenhausen | 34376 | Germany |
| Karlsruhe | 76137 | Germany |
| Leipzig | 04103 | Germany |
| Minden | 32429 | Germany |
| München | 80336 | Germany |
| Oldenburg | 26121 | Germany |
| Alexandroupoli | 68100 | Greece |
| Lecce | Apulia | 73100 | Italy |
| Naples | Campania | 80131 | Italy |
| Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Rome | Lazio | 00168 | Italy |
| Novara | Piedmont | 28100 | Italy |
| Sassari | Sardinia | 07100 | Italy |
| Pisa | Tuscany | 56124 | Italy |
| Padova | Veneto | 35128 | Italy |
| 's-Hertogenbosch | 5211 RW | Netherlands |
| Amersfoort | 3818 ES | Netherlands |
| Amsterdam | 1066 CX | Netherlands |
| Breda | 4818 CK | Netherlands |
| Eindhoven | 5623 EJ | Netherlands |
| Haarlem | 2035 RC | Netherlands |
| Nieuwegein | 3435 CM | Netherlands |
| Rotterdam | 3045 PM | Netherlands |
| Sittard-Geleen | 6162 BG | Netherlands |
| The Hague | 2504 LN | Netherlands |
| Zaandam | 1502 DV | Netherlands |
| Balashikha | 143900 | Russia |
| Irkutsk | 664035 | Russia |
| Krasnodar | 350086 | Russia |
| Moscow | 115478 | Russia |
| Saint Petersburg | 197089 | Russia |
| Bundang City | 463-802 | South Korea |
| Daegu | 700-712 | South Korea |
| Gyeonggi-do | 410-769 | South Korea |
| Seoul | 110746 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 137-807 | South Korea |
| Seoul | 138-736 | South Korea |
| Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Las Palmas de Gran Canaria | Las Palmas | 35016 | Spain |
| Madrid | Madrid | 28034 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Madrid | Madrid | 28046 | Spain |
| San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Gävle | 80187 | Sweden |
| Linköping | 58185 | Sweden |
| Lund | 22185 | Sweden |
| Uppsala | 751 85 | Sweden |
| Zurich | 8091 | Switzerland |
| Antalya | 07070 | Turkey (Türkiye) |
| Izmir | 35110 | Turkey (Türkiye) |
| Al Ain City | 15258 | United Arab Emirates |
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy. |
| FG002 | Bevacizumab +Pemetrexed Maintenance Trt Arm B | Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Treatment Phase |
|
|
The Intent-to-treat (ITT) population included all the participants that were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab Maintenance Trt Arm A | Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy. |
| BG001 | Bevacizumab +Pemetrexed Maintenance Trt Arm B | Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy. |
| BG002 | 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 |
| |||||||||||||||
| Sex: Female, Male | 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 | Progression Free Survival During Maintenance Treatment Phase | Progression free survival (PFS) is defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) , or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Progression is defined using (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter. | The ITT population included all the participants that were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to 21 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival During Maintenance Treatment Phase | Overall survival (OS) is assessed from the date of first induction treatment until the date of death. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter. | The ITT population included all the participants that were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to 21 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response Rate During Maintenance Treatment Phase | The best overall response rate (BORR) is defined as the percentage of participants having achieved confirmed Complete Response (CR) and Partial Response (PR) as the best overall response. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a greater than or equal to (≥) 30% decrease under baseline of the sum of diameters of all target lesions. Stable disease (SD) is defined as steady state of disease with neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter. | The ITT population which included all the participants that were randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 21 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response During Maintenance Treatment Phase | Duration of response is defined as the time in months from the initial start of response PR or better to the earlier of documented PD or death due to any cause. Participants who had neither progressed nor died at the date of clinical cutoff, who withdrew from the study, were lost to follow-up, or were without documented disease progression were censored at the date of the last available tumor assessment. The analysis was based on all participants with measurable disease at baseline who achieved response.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter. | The ITT population included all the participants that were randomized.Participants available at particular time point for assessment were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | Up to 21 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Disease Control During Maintenance Treatment Phase | Duration of disease control is defined as the time in months from randomization to the earlier of documented PD or death due to any cause. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter. | The ITT population included all the participants that were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to 21 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events and Serious Adverse Event | An adverse events (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution. | The safety population comprised of all participants who received at least one dose of study medication. Participants who received induction treatment and were not randomised to maintenance treatment are also included in analysis. | Posted | Number | Participants | Up to 21 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Marked Laboratory Abnormalities | Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from Baseline. The reference range for Platelets was 100-550 (10^9/L), for White blood cells (WBC) was 3.0-18.0 (10^9/L), for Lymphocytes was 0.70-7.60 (10^9/L), and Neutrophil 1.50-9.25 (10^9/L ). | The safety population comprised of all participants who received at least one dose of study medication. Participants who received induction treatment and were not randomised to maintenance treatment are also included in analysis. | Posted | Number | Participants | Up to 21 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life | European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Cancer 30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Lung Cancer 13 [EORTC QLQ-LC13]consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. QOL was assessed using Pre-Induction Baseline (Pre-ind BL), Maintenance (MTC), End of study (EOS) cycles. | The ITT population included all the participants that were randomized. | Posted | Mean | Standard Deviation | Score on scale | Up to 21 months |
|
Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Maintenance Treatment | A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.. | 70 | 128 | 105 | 128 | ||
| EG001 | Maintenance Treatment Arm A | Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis | 26 | 120 | 115 | 120 | ||
| EG002 | Maintenance Treatment Arm B | Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis.. | 42 | 125 | 120 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Scrub typhus | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tongue oedema | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haemorrhagic cyst | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Embolism arterial | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Iliac artery embolism | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vasculitis necrotising | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Viith nerve paralysis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac asthma | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatic vein thrombosis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Respiratory fume inhalation disorder | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| Withdrawal by Subject |
|
| Other reason |
|
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG002 | No Maintenance Trt | A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm. |
|
|
| OG002 | No Maintenance Trt | A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm... |
|
|
Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 mcg daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
|