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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019525-34 | EudraCT Number |
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This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the plasma concentration-time curve [AUC] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 milligram per square meter (mg/m^2) on Day 1 every 3 weeks or 80 mg/m^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab + Paclitaxel + Carboplatin | Experimental | Participants will receive bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol defined disease progression or until unacceptable toxicity (whichever occurred first). Participants will receive paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol defined disease progression, or unacceptable toxicity (whichever occurred first). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | 175 mg/m^2 on Day 1 every 3 weeks or at a dose of 80 mg/m^2 every week for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Adverse Event (AE) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was defined as the time between the date of first administration of any study treatment and the date of first documented protocol-defined disease progression (that is [i.e.], radiologically by Response Evaluation Criteria In Solid Tumors [RECIST], clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. Kaplan-Meier estimation was used for median time to PFS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | C1199ACI | Argentina | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27749456 | Derived | Oza AM, Selle F, Davidenko I, Korach J, Mendiola C, Pautier P, Chmielowska E, Bamias A, DeCensi A, Zvirbule Z, Gonzalez-Martin A, Hegg R, Joly F, Zamagni C, Gadducci A, Martin N, Robb S, Colombo N. Efficacy and Safety of Bevacizumab-Containing Therapy in Newly Diagnosed Ovarian Cancer: ROSiA Single-Arm Phase 3B Study. Int J Gynecol Cancer. 2017 Jan;27(1):50-58. doi: 10.1097/IGC.0000000000000836. |
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This study has been completed. However, the efficacy and safety results up to the clinical database cutoff date of 07 December 2014 are provided.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab + Paclitaxel + Carboplatin | Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 milligram per square meter (mg/m^2) IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (area under the plasma concentration-time curve [AUC] 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bevacizumab | Drug | 15 mg/kg intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each or until disease progression or unacceptable toxicity, whichever occurs first |
|
|
| Carboplatin | Drug | AUC 5-6 mg/ml/min on Day 1 every 3 weeks for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first |
|
| Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years |
| Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0 | Best overall response (BOR) according to RECIST Version 1.0 was categorized as: CR, PR, progressive disease (PD), stable disease (SD). CR: disappearance of all target lesions and non-target lesions. PR: >=30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. PD: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Participants with a BOR of CR and PR were defined as responders, while participants with a BOR of SD, PD, or unable to assess were defined as non-responders. | Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years |
| Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria | CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. Overall response according to CA-125 was only evaluated for participants with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the upper limit of normal (ULN). | 3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years) |
| Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria | Overall response was only evaluated for participants who were evaluable according to RECIST v1.0 with a measurable disease at baseline and/or according to CA-125 with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the ULN. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions). CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. | RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years |
| Duration of Objective Response (DOR) | DOR was defined as the time from the first documented response (CR or PR per RECIST v1.0), to the first documented protocol-defined disease progression (i.e., radiologically by RECIST, clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions). Disease progression: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). | Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years |
| Overall Survival (OS) | OS was defined as the time from the date of the first administration of any study treatment to the date of death, regardless of the cause of death. Participants without the event of death were censored at the last date in the study, defined as the latest date of the following: the date of first administration of study treatment, date of last study treatment, date of last visit, or date last known to be alive. Kaplan-Meier estimation was used for OS. | First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years |
| Biological Progression-free Interval | Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for participants with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment and initial normalization of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per participant on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment which never normalized). | 3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years) |
| Buenos Aires |
| C1280AEB |
| Argentina |
| Buenos Aires | C1426ANZ | Argentina |
| Rosario | S2002KDS | Argentina |
| San Miguel de Tucumán | T4000IAK | Argentina |
| Graz | 8020 | Austria |
| Graz | 8036 | Austria |
| Innsbruck | 6020 | Austria |
| Ried-innkreis | 4910 | Austria |
| Salzburg | 5020 | Austria |
| Steyr | 4400 | Austria |
| Vienna | 1090 | Austria |
| Vienna | 1130 | Austria |
| Villach | 9500 | Austria |
| Fortaleza | Ceará | 60125-120 | Brazil |
| Salvador | Estado de Bahia | 41950-610 | Brazil |
| Goiânia | Goiás | 74605-070 | Brazil |
| Curitiba | Paraná | 80530-010 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 20230-130 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90430-090 | Brazil |
| Piracicaba | São Paulo | 13419-155 | Brazil |
| São Paulo | São Paulo | 01246-000 | Brazil |
| São Paulo | São Paulo | 01308-050 | Brazil |
| São Paulo | São Paulo | 01317-000 | Brazil |
| São Paulo | São Paulo | 01509-010 | Brazil |
| Sofia | 1756 | Bulgaria |
| Varna | 9010 | Bulgaria |
| Veliko Tarnovo | 5000 | Bulgaria |
| Calgary | Alberta | T2N 4N2 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M5G 2M9 | Canada |
| Montreal | Quebec | H2L 4M1 | Canada |
| Québec | Quebec | G1R 3S1 | Canada |
| Aalborg | 9000 | Denmark |
| Roskilde | 4000 | Denmark |
| Vejle | 7100 | Denmark |
| Cairo | 11555 | Egypt |
| Tanta | Egypt |
| Tallinn | 11312 | Estonia |
| Tallinn | 13419 | Estonia |
| Tartu | 50406 | Estonia |
| Amiens | 80090 | France |
| Bordeaux | 33076 | France |
| Brest | 29200 | France |
| Caen | 14076 | France |
| Clermont-Ferrand | 63011 | France |
| Grenoble | 38028 | France |
| Lille | 59020 | France |
| Lyon | 69373 | France |
| Marseille | 13273 | France |
| Mougins | 06250 | France |
| Paris | 75231 | France |
| Paris | 75571 | France |
| Paris | 75651 | France |
| Paris | 75674 | France |
| Paris | 75908 | France |
| Paris | 75970 | France |
| Reims | 51056 | France |
| Strasbourg | 67065 | France |
| Toulouse | 31059 | France |
| Villejuif | 94805 | France |
| Athens | 115 28 | Greece |
| Athens | 11527 | Greece |
| Athens | 145 64 | Greece |
| Heraklion, Crete | 71110 | Greece |
| Larissa | 41 110 | Greece |
| Pátrai | 265 00 | Greece |
| Thessaloniki | 56429 | Greece |
| Hong Kong | 852 | Hong Kong |
| Hong Kong | Hong Kong |
| Budapest | 1122 | Hungary |
| Budapest | 1125 | Hungary |
| Debrecen | 4032 | Hungary |
| Pécs | 7624 | Hungary |
| Szeged | 6720 | Hungary |
| Bangalore | 560017 | India |
| Bangalore | 560054 | India |
| Hyderabad | 650034 | India |
| Jaipur | 302013 | India |
| Kochi | 682304 | India |
| New Delhi | 110029 | India |
| Pune | 411004 | India |
| Dublin | 7 | Ireland |
| Afula | 18101 | Israel |
| Beersheba | 8410101 | Israel |
| Haifa | 31096 | Israel |
| Haifa | 34362 | Israel |
| Holon | 58100 | Israel |
| Jerusalem | 91120-01 | Israel |
| Jerusalem | 9372212 | Israel |
| Kfar Saba | 44281 | Israel |
| Petah Tikva | 49100 | Israel |
| Ramat Gan | 52621 | Israel |
| Rehovot | 7610001 | Israel |
| Tel Aviv | 64239-06 | Israel |
| Naples | Campania | 80131 | Italy |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Meldola | Emilia-Romagna | 47014 | Italy |
| Rome | Lazio | 00128 | Italy |
| Rome | Lazio | 00157 | Italy |
| Genoa | Liguria | 16128 | Italy |
| Brescia | Lombardy | 25123 | Italy |
| Milan | Lombardy | 20141 | Italy |
| Milan | Lombardy | 20162 | Italy |
| Monza | Lombardy | 20052 | Italy |
| Saronno | Lombardy | 21047 | Italy |
| Novara | Piedmont | 28100 | Italy |
| Turin | Piedmont | 10126 | Italy |
| Turin | Piedmont | 10128 | Italy |
| Palermo | Sicily | 90146 | Italy |
| Florence | Tuscany | 50139 | Italy |
| Pisa | Tuscany | 56126 | Italy |
| Perugia | Umbria | 06123 | Italy |
| Terni | Umbria | 05100 | Italy |
| Ash Shuwaykh | 70653 | Kuwait |
| Daugavpils | 5417 | Latvia |
| Riga | LV 1079 | Latvia |
| Riga | LV-1002 | Latvia |
| Kaunas | 50009 | Lithuania |
| KlaipÄ—da | 92288 | Lithuania |
| Vilnius | 08660 | Lithuania |
| Distrito Federal | 14080 | Mexico |
| Oaxaca City | 68000 | Mexico |
| Toluca | 50180 | Mexico |
| Alkmaar | 1815 JD | Netherlands |
| Amsterdam | 1091 AC | Netherlands |
| Apeldoorn | 7334 DZ | Netherlands |
| Blaricum | 1261 AN | Netherlands |
| Breda | 4819 EV | Netherlands |
| Capelle aan den IJssel | NL 2900 AR | Netherlands |
| Deventer | 7416 SE | Netherlands |
| Dordrecht | 3318 AT | Netherlands |
| Eindhoven | 5623 EJ | Netherlands |
| Leidschendam | 2262 BA | Netherlands |
| Rotterdam | 3045 PM | Netherlands |
| Sittard-Geleen | 6162 BG | Netherlands |
| The Hague | 2512 VA | Netherlands |
| The Hague | 2545 CH | Netherlands |
| Utrecht | 3582 KE | Netherlands |
| Bitola | 7000 | North Macedonia |
| Skopje | 1000 | North Macedonia |
| Bydgoszcz | 85-796 | Poland |
| Warsaw | 03-242 | Poland |
| Porto | 4200-072 | Portugal |
| Bucharest | 022328 | Romania |
| Cluj-Napoca | 400015 | Romania |
| Iași | 700106 | Romania |
| Barnaul | 656049 | Russia |
| Moscow | 115478 | Russia |
| Obninsk, Kaluzhskaya Region | 249034 | Russia |
| Saint Petersburg | 197022 | Russia |
| Stavropol | 355045 | Russia |
| Ufa | 450054 | Russia |
| Dammam | 31444 | Saudi Arabia |
| Belgrade | 11000 | Serbia |
| Niš | 18000 | Serbia |
| Bratislava | 833 10 | Slovakia |
| Košice | 04001 | Slovakia |
| Ljubljana | 1000 | Slovenia |
| Maribor | 2000 | Slovenia |
| Durban | 4058 | South Africa |
| Johannesburg | 2193 | South Africa |
| Sandton | 2196 | South Africa |
| Albacete | Albacete | 02006 | Spain |
| Alicante | Alicante | 3010 | Spain |
| Elda | Alicante | 03600 | Spain |
| Badajoz | Badajoz | 06080 | Spain |
| Llerena (Badajoz) | Badajoz | 06900 | Spain |
| Palma de Mallorca | Balearic Islands | 07014 | Spain |
| Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Barcelona | Barcelona | 08003 | Spain |
| Barcelona | Barcelona | 08017 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Barcelona | Barcelona | 08906 | Spain |
| Manresa | Barcelona | 08243 | Spain |
| Burgos | Burgos | 09006 | Spain |
| Cáceres | Caceres | 10003 | Spain |
| Cadiz | Cadiz | 11009 | Spain |
| Jerez de la Frontera | Cadiz | 11407 | Spain |
| Castellon | Castellon | 12002 | Spain |
| Ciudad Real | Ciudad Real | 13005 | Spain |
| Córdoba | Cordoba | 14004 | Spain |
| Girona | Girona | 17007 | Spain |
| Granada | Granada | 18014 | Spain |
| Guadalajara | Guadalajara | 19002 | Spain |
| Donostia / San Sebastian | Guipuzcoa | 20080 | Spain |
| San Sebastián de los Reyes | Guipuzcoa | 28702 | Spain |
| Jaén | Jaen | 23007 | Spain |
| A Coruña | La Coruña | 15006 | Spain |
| Santiago de Compostela | La Coruña | 15706 | Spain |
| Las Palmas de Gran Canaria | Las Palmas | 35020 | Spain |
| Lugo | Lugo | 27003 | Spain |
| Leganés | Madrid | 28911 | Spain |
| Madrid | Madrid | 28002 | Spain |
| Madrid | Madrid | 28007 | Spain |
| Madrid | Madrid | 28033 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Madrid | Madrid | 28050 | Spain |
| Madrid | Madrid | 28222 | Spain |
| Málaga | Malaga | 29010 | Spain |
| Málaga | Malaga | 29011 | Spain |
| Navarra | Navarre | 31008 | Spain |
| Oviedo | Principality of Asturias | 33011 | Spain |
| Salamanca | Salamanca | 37007 | Spain |
| Segovia | Segovia | 40002 | Spain |
| Seville | Sevilla | 41009 | Spain |
| Seville | Sevilla | 41014 | Spain |
| Reus | Tarragona | 43204 | Spain |
| San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Santa Cruz de Tenerife | Tenerife | 38010 | Spain |
| Toledo | Toledo | 45004 | Spain |
| San Juan | Valencia | 03550 | Spain |
| Valencia | Valencia | 46009 | Spain |
| Valencia | Valencia | 46015 | Spain |
| Valencia | Valencia | 46017 | Spain |
| Valencia | Valencia | 46026 | Spain |
| Valladolid | Valladolid | 47010 | Spain |
| Barakaldo | Vizcaya | 48903 | Spain |
| Bilbao | Vizcaya | 48013 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
| Eskilstuna | 63188 | Sweden |
| Falun | 79182 | Sweden |
| Karlstad | 65185 | Sweden |
| Örebro | 701 85 | Sweden |
| Umeå | Sweden |
| Uppsala | 75185 | Sweden |
| Aarau | 5001 | Switzerland |
| Baden | 5405 | Switzerland |
| Bellinzona | 6500 | Switzerland |
| Bern | 3010 | Switzerland |
| Geneva | 1211 | Switzerland |
| Zurich | 8091 | Switzerland |
| Taipei | 110 | Taiwan |
| Taipei | 112 | Taiwan |
| Taoyuan Hsien | 333 | Taiwan |
| Ankara | 06230 | Turkey (Türkiye) |
| Ankara | 06500 | Turkey (Türkiye) |
| Diyarbakır | 10000 | Turkey (Türkiye) |
| Istanbul | 34390 | Turkey (Türkiye) |
| Montevideo | 11600 | Uruguay |
| COMPLETED |
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| NOT COMPLETED |
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Safety population: included all participants who received at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab + Paclitaxel + Carboplatin | Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first). |
| 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 | Percentage of Participants With at Least One Adverse Event (AE) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Safety population | Posted | Number | percentage of participants | Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS was defined as the time between the date of first administration of any study treatment and the date of first documented protocol-defined disease progression (that is [i.e.], radiologically by Response Evaluation Criteria In Solid Tumors [RECIST], clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. Kaplan-Meier estimation was used for median time to PFS. | Intent to treat population included all participants who received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0 | Best overall response (BOR) according to RECIST Version 1.0 was categorized as: CR, PR, progressive disease (PD), stable disease (SD). CR: disappearance of all target lesions and non-target lesions. PR: >=30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. PD: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Participants with a BOR of CR and PR were defined as responders, while participants with a BOR of SD, PD, or unable to assess were defined as non-responders. | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria | CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. Overall response according to CA-125 was only evaluated for participants with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the upper limit of normal (ULN). | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years) |
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| Secondary | Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria | Overall response was only evaluated for participants who were evaluable according to RECIST v1.0 with a measurable disease at baseline and/or according to CA-125 with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the ULN. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions). CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome. | Posted | Number | 95% Confidence Interval | percentage of participants | RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years |
| |||||||||||||||||||||||||||
| Secondary | Duration of Objective Response (DOR) | DOR was defined as the time from the first documented response (CR or PR per RECIST v1.0), to the first documented protocol-defined disease progression (i.e., radiologically by RECIST, clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions). Disease progression: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). | ITT population | Posted | Median | 95% Confidence Interval | months | Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of the first administration of any study treatment to the date of death, regardless of the cause of death. Participants without the event of death were censored at the last date in the study, defined as the latest date of the following: the date of first administration of study treatment, date of last study treatment, date of last visit, or date last known to be alive. Kaplan-Meier estimation was used for OS. | ITT population | Posted | Median | 95% Confidence Interval | months | First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years |
| |||||||||||||||||||||||||||
| Secondary | Biological Progression-free Interval | Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for participants with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment and initial normalization of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per participant on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment which never normalized). | Previous studies linking CA-125 levels with bevacizumab exposure as a potential secondary outcome measure for PFS did not produce any reliable information. Therefore, it was decided that data for this outcome measure should not be analyzed, as agreed with the study steering committee. | Posted | 3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years) |
|
Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab + Paclitaxel + Carboplatin | Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first). | 285 | 1,021 | 980 | 1,021 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal incarcerated hernia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gastric stenosis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haemorrhoids thrombosed | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Jejunal perforation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Mallory-weiss syndrome | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Infected lymphocele | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acute hepatitis C | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cholecystitis inefective | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Parotid abscess | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Peritoneal abscess | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Proctitis infectious | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Subdiaphragmatic abscess | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vulval cellulitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Embolism arterial | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Arterial thrombosis | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Malignant hypertension | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Renal infarct | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nicotinic acid deficiency | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Paraneoplastic dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rheumatic disorder | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase abnormal | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase abnormal | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase abnormal | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Bruxism | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Thyroid cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Intestinal operation | Surgical and medical procedures | MedDRA 18.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Non-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 | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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 |
| D056831 | Coordination Complexes |
Not provided
Not provided
|
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| Units | Counts |
|---|---|
| Participants |
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