Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)
Sponsor
EMD Serono (Industry)
Overall Status
Completed
CT.gov ID
NCT00409188
Collaborator
Merck KGaA, Darmstadt, Germany (Industry)
1,513
295
2
99
5.1
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.
A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Ancillary Trial: An exploratory investigation of immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.
The ancillary study is a sub-study within START. This is an exploratory investigation of the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination. The main objective is to evaluate whether administration of single-shot, low-dose cyclophosphamide followed by tecemotide (L-BLP25) vaccinations induces specific immune response in peripheral blood to BLP25 (the mucinous glycoprotein 1 [MUC1] antigen) as well as a modulation of cellular and soluble components of the immune response in subjects with unresectable stage III NSCLC.
Twenty-five of the European START sites will participate in the ancillary study.
Sample size: up to 60 to 80 subjects
All inclusion criteria specified in the START clinical trial protocol except for hemoglobin
= 100 gram/Liter (g/L)
All exclusion criteria are the same as specified in the START clinical trial protocol
Schedule of events: Blood samples will be taken at baseline, visit week 4, 8 13 and 25 (80 milliliter (mL) whole blood each)
Study Design
Study Type:
Interventional
Actual Enrollment
:
1513 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease.
Study Start Date
:
Jan 1, 2007
Actual Primary Completion Date
:
Apr 1, 2012
Actual Study Completion Date
:
Apr 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tecemotide (L-BLP25)
|
Biological: Tecemotide (L-BLP25)
After receiving cyclophosphamide, participants will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression is documented.
Drug: Single low dose cyclophosphamide
A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before first tecemotide (L-BLP25) vaccination.
|
| Placebo Comparator: Placebo
|
Drug: Placebo
A single infusion (IV) of 0.9% Saline solution instead of cyclophosphamide but in the same calculated dose will be given three days before first placebo vaccination. Subjects will then receive eight consecutive weekly subcutaneous vaccinations with placebo at weeks 0; 1; 2; 3; 4; 5; 6 and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at week 13, until disease progression is documented.
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [Up to 66 months]
Overall survival time was defined as the time from randomization to death. Participants without events were censored at the last date they were known to be alive or the clinical cut-off date, whatever was earlier.
Secondary Outcome Measures
- Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS) [Up to 66 months]
Time to symptom progression (TTSP) was measured by LCSS. Symptomatic progression was defined as an increase (worsening) of the Average Symptomatic Burden Index (ASBI that is, the mean of the six major lung cancer specific symptom scores of the LCSS patient scale - ranging from 0 to 100 where higher score indicates worst outcome). Worsening was defined as a 10% increase in the scale breadth from the baseline score. TTSP is defined as the time from randomization to worsening in ASBI. Participants without event are censored at the date of the last LCSS assessment.
- Time To Progression (TTP) [Up to 66 months]
Time from randomization to disease progression. Disease progression was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 [RECIST v1.0]) as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions.
- One-, Two- and Three-year Survival Rate [Years 1, 2, and 3]
The percentages of participants who were alive at 1, 2, and 3 years were calculated as a cumulative percentage by Kaplan-Meier survival analysis approach.
- Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions [From first dose up to 42 days after the last dose of the trial treatment]
Treatment -emergent adverse events were defined as those with onset or worsening occurring at or after the first dosing day of study medication and up to 42 days after the last administration of any study drug or the clinical cut-off date. Injection site reactions were reported as assessed by the Investigator.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically or cytologically documented unresectable stage III non-small cell lung cancer (NSCLC)
-
Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST), after primary chemoradiotherapy (either sequential or concomitant) for unresectable stage III disease, within 4 weeks (28 days) prior to randomization
-
Receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of >=50 Gray (Gy). Subjects must have completed the primary thoracic chemo-radiotherapy at least four weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary chemo-radiotherapy are eligible
-
Geographically accessible for ongoing follow-up, and committed to comply with the designated visits
-
An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
-
A platelet count > 140 x 109/Liter; white blood cells (WBC) > 2.5 x 109/Liter and hemoglobin > 90 gram per liter (g/L)
Exclusion Criteria:
Pre-Therapies:
-
Undergone lung cancer specific therapy (including surgery) other than primary chemo-radiotherapy
-
Receipt of immunotherapy (e.g. interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor , granulocyte colony stimulating factor , macrophage-colony stimulating factor ], monoclonal antibodies) within 4 weeks (28 days) prior to randomization
-
Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks (28 days) prior to randomization
Disease Status:
-
Metastatic disease
-
Malignant pleural effusion at initial diagnosis and/or at study entry
-
Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
-
Autoimmune disease
-
A recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies
-
Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed)
-
Known Hepatitis B and/or C
Physiological Functions:
-
Clinically significant hepatic dysfunction
-
Clinically significant renal dysfunction
-
Clinically significant cardiac disease
-
Splenectomy
-
Infectious process that in the opinion of the investigator could compromise the subject's ability to mount an immune response
Standard Safety:
-
Pregnant or breast-feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
-
Known drug abuse/alcohol abuse
-
Legal incapacity or limited legal capacity
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Saint Edward Mercy Medical Center | Fort Smith | Arkansas | United States | 72901 |
| 2 | Pacific Cancer Medical Center | Anaheim | California | United States | 92801 |
| 3 | Glendale Adventist Medical Center | Glendale | California | United States | 91206 |
| 4 | Norris Cancer Hospital | Los Angeles | California | United States | 90033 |
| 5 | Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | United States | 90048 |
| 6 | Clinical Trials and Research Associates, Inc. | Montebello | California | United States | 90640 |
| 7 | Desert Hematology Oncology Medical Group, Inc | Rancho Mirage | California | United States | |
| 8 | Stockton Hematology Oncology Medical Group, Inc. | Stockton | California | United States | 95204 |
| 9 | University of Colorado Cancer Center | Denver | Colorado | United States | 80045 |
| 10 | Pasco Hernando Oncology Associates P.A | Brooksville | Florida | United States | 34613 |
| 11 | University of Miami, Sylvester Comprehensive Cancer Center | Miami | Florida | United States | |
| 12 | Pasco Hernando Oncology Associates, PA | New Port Richey | Florida | United States | 34652 |
| 13 | Florida Hospital Memorial System | Ormond Beach | Florida | United States | 32174 |
| 14 | Southern Illinois Hematology/Oncology | Centralia | Illinois | United States | 62801 |
| 15 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 16 | Joliet Oncology-Hematology Associates, Ltd. | Joliet | Illinois | United States | 60435 |
| 17 | Kentucky Cancer Center | Hazard | Kentucky | United States | 41701 |
| 18 | Leonard J. Chabert Medical Center | Houma | Louisiana | United States | |
| 19 | Hematology and Oncology Specialists, LLC | Metarie | Louisiana | United States | 70006 |
| 20 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 21 | University of Maryland, Marlene and Steward Greenbaum Cancer Center | Baltimore | Maryland | United States | |
| 22 | Lahey Clinic | Burlington | Massachusetts | United States | |
| 23 | Oncology Care Associates | Saint Joseph | Michigan | United States | 49085 |
| 24 | University of Minnesota Physicians, Masonic Cancer Center | Minneapolis | Minnesota | United States | |
| 25 | Saint Louis University Cance Center | Saint Louis | Missouri | United States | |
| 26 | Deaconess Billings Clinic | Billings | Montana | United States | 59101 |
| 27 | Big Sky Oncology, Sletten Cancer Institute | Great Falls | Montana | United States | 59405 |
| 28 | Nebraska Cancer Care, LLC | Hastings | Nebraska | United States | 68901 |
| 29 | Southeast Nebraska Cancer Center | Lincoln | Nebraska | United States | 68510 |
| 30 | St. Vincents Comprehensive Cancer Center | New York | New York | United States | 10011 |
| 31 | Hematology Oncology Associates of Rockland | Nyack | New York | United States | 10960 |
| 32 | Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27599 |
| 33 | Carolinas Hematology-Oncology | Charlotte | North Carolina | United States | 28203 |
| 34 | Hanover Medical Specialts PA | Wilmington | North Carolina | United States | 28401 |
| 35 | Gabrail Cancer Center | Canton | Ohio | United States | 44718 |
| 36 | University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106 |
| 37 | Signal Point Clinical Research Center, LLC | Middletown | Ohio | United States | 45042 |
| 38 | Southwestern Regional Medical Center | Tulsa | Oklahoma | United States | 74133 |
| 39 | Southwestern Regional Medical Center | Tulsa | Oklahoma | United States | |
| 40 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
| 41 | Univ. of Pennsylvania Abramson Cancer Center | Philadelphia | Pennsylvania | United States | 19104 |
| 42 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 43 | The Jones Clinic, PC | Germantown | Tennessee | United States | 38138 |
| 44 | Center for Oncology Research | Dallas | Texas | United States | 75230 |
| 45 | John Peter Smith Center for Cancer Care | Fort Worth | Texas | United States | 76104 |
| 46 | The Center for Cancer and Blood Disorders | Fort Worth | Texas | United States | 76104 |
| 47 | Cancer Therapy & Research Center, Institute for Drug Development | San Antonio | Texas | United States | 78229 |
| 48 | Fairfax-Northern Virginia Hematology Oncology, PC | Fairfax | Virginia | United States | 22031 |
| 49 | Wheeling Hospital | Wheeling | West Virginia | United States | 26003 |
| 50 | Hospital Italiano Regional del Sur | Bahia Blanca | Buenos Aires | Argentina | |
| 51 | Paliar | Capital, Buenos Aires | Buenos Aires | Argentina | |
| 52 | Corporacion Medica General San Martin | San Martin | Buenos Aires | Argentina | |
| 53 | Centro Oncologico de Roario | Rosario | Santa Fe | Argentina | |
| 54 | Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC) | Ciudad Autonoma de Buenos Aires | Argentina | ||
| 55 | Instituto Especializado Alexander Fleming | Ciudad Autonoma de Buenos Aires | Argentina | ||
| 56 | Sociedad Intaliana de Beneficencia en Buenos Aires, Hospital Italiano | Ciudad Autonoma de Buenos Aires | Argentina | ||
| 57 | Clinica Universitaria Reina Fabiola | Cordoba | Argentina | ||
| 58 | Research Site | Tandil | Argentina | ||
| 59 | Research Site | Nedlands | Western Australia | Australia | |
| 60 | Research Site | Bankstown, NSW | Australia | ||
| 61 | Research Site | Camperdown | Australia | ||
| 62 | Research Site | Heidelberg | Australia | ||
| 63 | Research Site | Kingswood | Australia | ||
| 64 | Research Site | Saint Leonards | Australia | ||
| 65 | Research Site | Woolloongabba | Australia | ||
| 66 | Research Site | Graz | Styria | Austria | |
| 67 | Research Site | Linz | Upper Austria | Austria | |
| 68 | Research Site | Inssbruck | Austria | ||
| 69 | Research Site | Salzburg | Austria | ||
| 70 | Research Site | Wein, Venna | Austria | ||
| 71 | Research Site | Wels | Austria | ||
| 72 | Research Site | Wien | Austria | ||
| 73 | Research Site | Brasschaat | Belgium | ||
| 74 | Research Site | Brussels | Belgium | ||
| 75 | Research Site | Haine-Saint Paul | Belgium | ||
| 76 | Research Site | Leuven | Belgium | ||
| 77 | Research Site | Liege | Belgium | ||
| 78 | Research Site | Mechelen | Belgium | ||
| 79 | Nugieo de Oncologia da Bahia | Salvador | Bahia | Brazil | |
| 80 | Hospital das Clinicas da Faculdade de Medinina de Univeridade | São Paulo | De ao Paulo | Brazil | |
| 81 | Hospital LifeCenter | Belo Horizonte | Minas Gerais | Brazil | |
| 82 | Hospital Nossa Senhora da Conceicao, Centro de Pesquisas Medicas e Ensaios Clinicos | Porto Alegre | Rio Grande Do Sol | Brazil | |
| 83 | Associacao Hospital de Caridade Ijui | Ijuí | Rio Grande Do Sul | Brazil | |
| 84 | Hospital de Clinicas de Porto Alegre, Dept. de Endocrinologia | Porto Alegre | Rio Grande Do Sul | Brazil | |
| 85 | Hospital Sao Lucas-Pucrs | Porto Alegre | Rio Grande Do Sul | Brazil | |
| 86 | Research Site | Porto Algre | Rio Grande Do Sul | Brazil | |
| 87 | Centro de Oncologia de Campinas - OCC | Campinas | Sao Paulo | Brazil | |
| 88 | Fundacao Hospital Amaral Carvalho | Jau | Sao Paulo | Brazil | |
| 89 | Instituto de Oncologia de Sorocaba | Sorocaba | Sao Paulo | Brazil | |
| 90 | Research Site | Ondina-Salvdor | Brazil | ||
| 91 | Instituto Nacional do Cancer - INCA | Rio de Janeriro | Brazil | ||
| 92 | Instituto do Cancer Arnaldo Vieira de Caralho-Onco-pneumonia | Sao Paulo | Brazil | ||
| 93 | Santa Casa de Misericordia De Sao Paulo | Sao Paulo | Brazil | ||
| 94 | Tom Baker Cancer Center | Calgary | Alberta | Canada | |
| 95 | Cross Cancer Institue | Edmonton | Alberta | Canada | |
| 96 | Frazer Valley Cancer Center | Surrey | British Columbia | Canada | |
| 97 | British Columbia Cancer Agency | Vancouver | British Columbia | Canada | |
| 98 | Vancouver Island Cancer Center | Victoria | British Columbia | Canada | |
| 99 | Cancer Care Manitoba | Winnipeg | Manitoba | Canada | |
| 100 | Capital District Health Authority | Halifax | Nova Scotia | Canada | |
| 101 | Cape Breton Districk Health Authority Cancer Care | Sydney | Nova Scotia | Canada | |
| 102 | Juravinski Cancer Center | Hamilton | Ontario | Canada | |
| 103 | Niagara Health System | Saint Catharines | Ontario | Canada | |
| 104 | Thunder Bay Regional Health Science Center Northwestern Ontario Regional Center | Thunder Bay | Ontario | Canada | |
| 105 | Mount Sinai Hospital | Toronto | Ontario | Canada | |
| 106 | Princess Margaret Hospital | Toronto | Ontario | Canada | |
| 107 | Windsor Regional Cancer Center | Windsor | Ontario | Canada | |
| 108 | Hopital Notre Dame | Montreal | Quebec | Canada | |
| 109 | Jewish General Hospital | Montreal | Quebec | Canada | |
| 110 | Hopital Laval | Sainte-Foy | Quebec | Canada | |
| 111 | Research Site | Beijing | China | ||
| 112 | Research Site | Guangzhou | China | ||
| 113 | Research Site | Shanghai | China | ||
| 114 | Research Site | Hradec Králové | Czech Republic | ||
| 115 | Research Site | Ostrava-Poruba | Czech Republic | ||
| 116 | Research Site | Prague | Czech Republic | ||
| 117 | Research Site | Praha 2 | Czech Republic | ||
| 118 | Research Site | Praha | Czech Republic | ||
| 119 | Research Site | Usti nad Labem | Czech Republic | ||
| 120 | Research Site | Herlev | Denmark | ||
| 121 | Research Site | Odense C | Denmark | ||
| 122 | Research Site | Besancon | Franche-Comte | France | |
| 123 | Research Site | Pierre-Benite Cedex | Rhone-Alpes | France | |
| 124 | Research Site | Beuvry | France | ||
| 125 | Research Site | Brest | France | ||
| 126 | Research Site | Caen | France | ||
| 127 | Research Site | Chauny | France | ||
| 128 | Research Site | Marseille Cedex | France | ||
| 129 | Research Site | Marseille | France | ||
| 130 | Research Site | Nancy | France | ||
| 131 | Research Site | Nantes-Saint Herblain | France | ||
| 132 | Research Site | Paris Cedex 15 | France | ||
| 133 | Research Site | Perpignan | France | ||
| 134 | Research Site | Poitiers Cedex | France | ||
| 135 | Research Site | Strasbourg Cedex | France | ||
| 136 | Research Site | Essen | Nordrhein-Westfalen | Germany | |
| 137 | Research Site | Hemer | Nordrhein-Westfalen | Germany | |
| 138 | Research Site | Mainz | Rheinland-Pfalz | Germany | |
| 139 | Research Site | Homburg | Saar | Germany | |
| 140 | Research Site | Berlin | Germany | ||
| 141 | Research Site | Coswig | Germany | ||
| 142 | Research Site | Essen | Germany | ||
| 143 | Research Site | Frankfurt am Main | Germany | ||
| 144 | Research Site | Freiburg | Germany | ||
| 145 | Research Site | Gauting | Germany | ||
| 146 | Research Site | Großhansdorf | Germany | ||
| 147 | Research Site | Hamburg | Germany | ||
| 148 | Reseach Site | Heidelberg | Germany | ||
| 149 | Research Site | Kassel | Germany | ||
| 150 | Research Site | Kiel | Germany | ||
| 151 | Research Site | Koln | Germany | ||
| 152 | Research Site | Leipzig | Germany | ||
| 153 | Research Site | Magdeburg | Germany | ||
| 154 | Research Site | Mainz | Germany | ||
| 155 | Research Site | Minden | Germany | ||
| 156 | Research Site | Muchen | Germany | ||
| 157 | Research Site | München | Germany | ||
| 158 | Research Site | Oldenburg | Germany | ||
| 159 | Research Site | Rostock | Germany | ||
| 160 | Research Site | Maroussi | Athens | Greece | |
| 161 | Research Site | Athens | Attica | Greece | |
| 162 | Research Site | Thessaloniki | Nea Efkarpia | Greece | |
| 163 | Research Site | Athens | Greece | ||
| 164 | Research Site | Chidari, Athens | Greece | ||
| 165 | Research Site | Heraklion | Greece | ||
| 166 | Research Site | Shatin | New Territories | Hong Kong | |
| 167 | Research Site | Hong Kong | Hong Kong | ||
| 168 | Research Site | Budapest | Hungary | ||
| 169 | Research Site | Mátraháza | Hungary | ||
| 170 | Research Site | Nyíregyháza | Hungary | ||
| 171 | Research Site | Tatabayana | Hungary | ||
| 172 | Research Site | Chennai | India | ||
| 173 | Research Site | Hyderabad | India | ||
| 174 | Research Site | Mumbai | India | ||
| 175 | Research Site | New Delhi | India | ||
| 176 | Research Site | Vellore | India | ||
| 177 | Research Site | Dublin | Ireland | ||
| 178 | Research Site | Tel Hashomer | Tel Avir | Israel | |
| 179 | Research Site | Beer Sheva | Israel | ||
| 180 | Research Site | Haifa | Israel | ||
| 181 | Research Site | Jerusalem | Israel | ||
| 182 | Research Site | Kfar Saba | Israel | ||
| 183 | Research Site | Petach Tikva | Israel | ||
| 184 | Research Site | Tel Aviv | Israel | ||
| 185 | Research Site | Zerifin | Israel | ||
| 186 | Research Site | Candiolo | Torino | Italy | |
| 187 | Research Site | Avelino | Italy | ||
| 188 | Research Site | Bologna | Italy | ||
| 189 | Research Site | Carpi | Italy | ||
| 190 | Research Site | Chieti | Italy | ||
| 191 | Research Site | Forli | Italy | ||
| 192 | Research Site | Genova | Italy | ||
| 193 | Research Site | Meldola | Italy | ||
| 194 | Research Site | Milano | Italy | ||
| 195 | Research Site | Napoli | Italy | ||
| 196 | Research Site | Orbassano-Torino | Italy | ||
| 197 | Research Site | Palermo | Italy | ||
| 198 | Research Site | Parma | Italy | ||
| 199 | Research Site | Rome | Italy | ||
| 200 | Research Site | Rozzano-Milano | Italy | ||
| 201 | Research Site | Sassari | Italy | ||
| 202 | Research Site | Trento | Italy | ||
| 203 | Research Site | Goyang-si | Gyeonggi-do | Korea, Republic of | |
| 204 | Research Site | Seoul | Gyeonggi-Do | Korea, Republic of | |
| 205 | Research Site | Seoul | Korea, Republic of | ||
| 206 | Consultorio del | Morelia | Michoacan | Mexico | |
| 207 | Centro Oncologico de Chihuahua | Chihuahua | Mexico | ||
| 208 | Instituto Nacional de Cancerologia (INCAN) | Mexico City | Mexico | ||
| 209 | Research Site | Amsterdam | Noord-Holland | Netherlands | |
| 210 | Research Site | Amsterdam | Netherlands | ||
| 211 | Research Site | Eindhoven | Netherlands | ||
| 212 | Research Site | Hoofdrop | Netherlands | ||
| 213 | Research Site | Tilburg | Netherlands | ||
| 214 | Research Site | Zwolle | Netherlands | ||
| 215 | Research Site | Warszawa | Mazowieckie | Poland | |
| 216 | Research Site | Bialystok | Poland | ||
| 217 | Research Site | Bydgoszcz | Poland | ||
| 218 | Research Site | Bytom | Poland | ||
| 219 | Research Site | Gdynia | Poland | ||
| 220 | Research Site | Kraków | Poland | ||
| 221 | Genova | Lodz | Poland | ||
| 222 | Research Site | Olsztyn | Poland | ||
| 223 | Research Site | Otwock | Poland | ||
| 224 | Research Site | Poznan | Poland | ||
| 225 | Research Site | Torun | Poland | ||
| 226 | Research Site | Warsaw | Poland | ||
| 227 | Genova | Warszawa | Poland | ||
| 228 | Research Site | Wroclaw | Poland | ||
| 229 | Research Site | Zabrze | Poland | ||
| 230 | Genova | Coimbra | Portugal | ||
| 231 | Genova | Lisboa | Portugal | ||
| 232 | Genova | Porto | Portugal | ||
| 233 | Genova | Santa Maria de Feira | Portugal | ||
| 234 | Research Site | Bucharest | Romania | ||
| 235 | Research Site | Bucuresti | Romania | ||
| 236 | Research Site | Cluj-Napoca | Romania | ||
| 237 | Research Site | Iasi | Romania | ||
| 238 | Research Site | Sibiu | Romania | ||
| 239 | Research Site | Suceava | Romania | ||
| 240 | Research Site | Timisoara | Romania | ||
| 241 | Reseaerch Site | Kazan | Tatarstan | Russian Federation | |
| 242 | Research Site | Yaroslavl | Yaroslavlr | Russian Federation | |
| 243 | Research Site | Barnaul | Russian Federation | ||
| 244 | Genova | Chelaybinsk | Russian Federation | ||
| 245 | Research Site | Ivanovo | Russian Federation | ||
| 246 | Research Site | Kazan | Russian Federation | ||
| 247 | Research Site | Moscow | Russian Federation | ||
| 248 | Research Site | Obninsk | Russian Federation | ||
| 249 | Research Site | Saint Petersburg | Russian Federation | ||
| 250 | Research Site | Tomsk | Russian Federation | ||
| 251 | Research Site | Voronezh | Russian Federation | ||
| 252 | Research Site | Singapore | Singapore | ||
| 253 | Research Site | Bratislava | Slovakia | ||
| 254 | Research Site | Kosice | Slovakia | ||
| 255 | Research Site | Nitra | Slovakia | ||
| 256 | Research Site | Mataro | Barcelona | Spain | |
| 257 | Research Site | Barakaldo | Bilbao | Spain | |
| 258 | Research Site | Donostia-San Sebastian | Guipuzcoa | Spain | |
| 259 | Research Site | A Coruna | Spain | ||
| 260 | Research Site | Alicante | Spain | ||
| 261 | Research Site | Barcelona | Spain | ||
| 262 | Research Site | Burgos | Spain | ||
| 263 | Research Site | Girona | Spain | ||
| 264 | Research Site | Jaen | Spain | ||
| 265 | Research Site | Lugo | Spain | ||
| 266 | Research Site | Madrid | Spain | ||
| 267 | Research Site | Malaga | Spain | ||
| 268 | Research Site | Gävle | Sweden | ||
| 269 | Research Site | Göteborg | Sweden | ||
| 270 | Research Site | Lund | Sweden | ||
| 271 | Research Site | Stockholm | Sweden | ||
| 272 | Research Site | Umea | Sweden | ||
| 273 | Research Site | Uppsala | Sweden | ||
| 274 | Research Site | Basel | Switzerland | ||
| 275 | Research Site | Geneve | Switzerland | ||
| 276 | Research Site | Genève | Switzerland | ||
| 277 | Research Site | Winterthur | Switzerland | ||
| 278 | Research Site | Kaohsiung | Taiwan | ||
| 279 | Research Site | Taichung | Taiwan | ||
| 280 | Research Site | Tainan | Taiwan | ||
| 281 | Research Site | Taipei | Taiwan | ||
| 282 | Research Site | Tao-Yuan | Taiwan | ||
| 283 | Research Site | Cornwall | United Kingdom | ||
| 284 | Research Site | Edinburgh | United Kingdom | ||
| 285 | Research Site | Glasgow | United Kingdom | ||
| 286 | Research Site | Guildford | United Kingdom | ||
| 287 | Research Site | Inverness | United Kingdom | ||
| 288 | Research Site | Leeds | United Kingdom | ||
| 289 | Research Site | Leicester | United Kingdom | ||
| 290 | Research Site | London | United Kingdom | ||
| 291 | Research Site | Manchester | United Kingdom | ||
| 292 | Research Site | Southampton | United Kingdom | ||
| 293 | Research Site | Surrey | United Kingdom | ||
| 294 | Research Site | Torquay | United Kingdom | ||
| 295 | Research Site | Wirral | United Kingdom |
Sponsors and Collaborators
- EMD Serono
- Merck KGaA, Darmstadt, Germany
Investigators
- Study Director: Medical Responsible, EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
- Butts C, Socinski MA, Mitchell P, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Ciuleanu TE, Bosquée L, Trigo JM, Spira A, Tremblay L, Nyman J, Ramlau R, Helwig C, Falk MH, Shepherd FA. START: A phase III study of L-BLP25 cancer immunotherapy for unresectable stage III non-small cell lung cancer. American Society of Clinical Oncology - 49th Annual Meeting. 2013; Abstr No. 7500.
- Mitchell P, Butts C, Socinski M, Thatcher N, Wichardt-Johansson G, Ellis P, Gladkov O, Pereira J, Eberhardt W, Horwood K, Szczesna A, Helwig C, Schröder A, Shepherd F. Tecemotide (L-BLP25) in unresectable stage III non-small cell lung cancer in the phase III START study: Further endpoint and exploratory biomarker results. World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2779.
- Shepherd FA, Socinski MA, Mitchell P, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Helwig C, Schroeder A, Butts C. Updated analysis and secondary endpoints with L-BLP25 in unresectable stage III non-small cell lung cancer in the phase III START study. European Society for Medical Oncology 38th Congress - ECCO 17, ESMO 38, ESTRO 32. 2013. Abstr No. 3419.
- Socinski M, Butts C, Mitchell P, Thatcher N, Scagliotti G, Robinet G, Martin C, Zukin M, Ragulin Y, Bonomi P, Yang CH, Regnault A, Helwig C, de Nigris E, Shepherd F. Exploration of patient health status as measured by the generic preference-based questionnaire EQ-5D alongside the START trial of tecemotide in non-small cell lung cancer. World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2744.
- Thatcher N, Shepherd FA, Mitchell P, Socinski MA, Paredes A, Lambrechts M, Thomas M, Kollmeier J, Zemanová M, Sadjadian P, Peylan-Ramu N, Helwig C, Schröder A, Butts C. Geographic differences in the combined-modality treatment of stage III unresectable non-small cell lung cancer: Results from a global phase III trial of tecemotide (L-BLP25). World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2712.
Responsible Party:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00409188
Other Study ID Numbers:
- EMR 63325-001
First Posted:
Dec 8, 2006
Last Update Posted:
Nov 20, 2015
Last Verified:
Oct 1, 2015
Keywords provided by EMD Serono
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | First/last participant (informed consent): 25 January 2007/31 October 2011. Data cut-off for primary endpoint analysis: 08 August 2012. Participants randomized at 264 centers in 33 countries worldwide. |
|---|---|
| Pre-assignment Detail | A total of 1908 participants were screened for eligibility and 1513 participants were enrolled and randomized. |
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Saline + Placebo |
|---|---|---|
| Arm/Group Description | A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented. | A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented. |
| Period Title: Overall Study | ||
| STARTED | 1006 | 507 |
| COMPLETED | 623 | 332 |
| NOT COMPLETED | 383 | 175 |
Baseline Characteristics
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Saline + Placebo | Total |
|---|---|---|---|
| Arm/Group Description | A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented. | A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented. | Total of all reporting groups |
| Overall Participants | 1006 | 507 | 1513 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
60.7
(9.1)
|
60.9
(9.0)
|
60.8
(9.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
315
31.3%
|
162
32%
|
477
31.5%
|
| Male |
691
68.7%
|
345
68%
|
1036
68.5%
|
Outcome Measures
| Title | Overall Survival |
|---|---|
| Description | Overall survival time was defined as the time from randomization to death. Participants without events were censored at the last date they were known to be alive or the clinical cut-off date, whatever was earlier. |
| Time Frame | Up to 66 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary analysis set (modified intention-to-treat [ITT] population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold. |
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Saline + Placebo |
|---|---|---|
| Arm/Group Description | A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented. | A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented. |
| Measure Participants | 829 | 410 |
| Median (95% Confidence Interval) [months] |
25.6
|
22.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tecemotide (L-BLP25) + Cyclophosphamide, Saline + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1566 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.893 | |
| Confidence Interval |
(2-Sided) 95% 0.763 to 1.044 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS) |
|---|---|
| Description | Time to symptom progression (TTSP) was measured by LCSS. Symptomatic progression was defined as an increase (worsening) of the Average Symptomatic Burden Index (ASBI that is, the mean of the six major lung cancer specific symptom scores of the LCSS patient scale - ranging from 0 to 100 where higher score indicates worst outcome). Worsening was defined as a 10% increase in the scale breadth from the baseline score. TTSP is defined as the time from randomization to worsening in ASBI. Participants without event are censored at the date of the last LCSS assessment. |
| Time Frame | Up to 66 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold. "N" signifies the number of participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Saline + Placebo |
|---|---|---|
| Arm/Group Description | A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented. | A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented. |
| Measure Participants | 829 | 409 |
| Median (95% Confidence Interval) [months] |
14.2
|
11.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tecemotide (L-BLP25) + Cyclophosphamide, Saline + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0226 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.845 | |
| Confidence Interval |
(2-Sided) 95% 0.732 to 0.977 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time To Progression (TTP) |
|---|---|
| Description | Time from randomization to disease progression. Disease progression was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 [RECIST v1.0]) as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions. |
| Time Frame | Up to 66 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold. |
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Saline + Placebo |
|---|---|---|
| Arm/Group Description | A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented. | A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented. |
| Measure Participants | 829 | 410 |
| Median (95% Confidence Interval) [months] |
10.0
|
8.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tecemotide (L-BLP25) + Cyclophosphamide, Saline + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0528 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.868 | |
| Confidence Interval |
(2-Sided) 95% 0.752 to 1.002 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | One-, Two- and Three-year Survival Rate |
|---|---|
| Description | The percentages of participants who were alive at 1, 2, and 3 years were calculated as a cumulative percentage by Kaplan-Meier survival analysis approach. |
| Time Frame | Years 1, 2, and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold. |
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Saline + Placebo |
|---|---|---|
| Arm/Group Description | A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented. | A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented. |
| Measure Participants | 829 | 410 |
| Year 1 |
77.0
7.7%
|
74.7
14.7%
|
| Year 2 |
50.8
5%
|
45.9
9.1%
|
| Year 3 |
40.2
4%
|
37.0
7.3%
|
| Title | Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions |
|---|---|
| Description | Treatment -emergent adverse events were defined as those with onset or worsening occurring at or after the first dosing day of study medication and up to 42 days after the last administration of any study drug or the clinical cut-off date. Injection site reactions were reported as assessed by the Investigator. |
| Time Frame | From first dose up to 42 days after the last dose of the trial treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all participants who received at least 1 dose of trial treatment (cyclophosphamide, tecemotide, saline, or placebo). Participants were reported based on the actual treatment received (as-treated). |
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Saline + Placebo |
|---|---|---|
| Arm/Group Description | A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented. | A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented. |
| Measure Participants | 1024 | 477 |
| Treatment Emergent Adverse events |
938
93.2%
|
432
85.2%
|
| Injection site reaction |
176
17.5%
|
56
11%
|
Adverse Events
| Time Frame | Up to 66 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety analysis set included all participants who received at least 1 dose of trial treatment (cyclophosphamide, tecemotide, saline, or placebo). Participants were reported based on the actual treatment received (as-treated). | |||
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Saline + Placebo | ||
| Arm/Group Description | A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented. | A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented. | ||
All Cause Mortality |
||||
| Tecemotide (L-BLP25) + Cyclophosphamide | Saline + Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Tecemotide (L-BLP25) + Cyclophosphamide | Saline + Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 303/1024 (29.6%) | 151/477 (31.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 3/1024 (0.3%) | 2/477 (0.4%) | ||
| Haemolytic anaemia | 0/1024 (0%) | 1/477 (0.2%) | ||
| Hypocoagulable state | 1/1024 (0.1%) | 0/477 (0%) | ||
| Pancytopenia | 3/1024 (0.3%) | 0/477 (0%) | ||
| Thrombocytopenia | 3/1024 (0.3%) | 0/477 (0%) | ||
| Cardiac disorders | ||||
| Acute coronary syndrome | 0/1024 (0%) | 1/477 (0.2%) | ||
| Acute myocardial infarction | 1/1024 (0.1%) | 4/477 (0.8%) | ||
| Angina pectoris | 3/1024 (0.3%) | 3/477 (0.6%) | ||
| Arrhythmia | 0/1024 (0%) | 1/477 (0.2%) | ||
| Atrial fibrillation | 8/1024 (0.8%) | 3/477 (0.6%) | ||
| Atrial flutter | 3/1024 (0.3%) | 0/477 (0%) | ||
| Atrioventricular block second degree | 0/1024 (0%) | 1/477 (0.2%) | ||
| Cardiac disorder | 1/1024 (0.1%) | 0/477 (0%) | ||
| Cardiac failure congestive | 0/1024 (0%) | 1/477 (0.2%) | ||
| Cardiac tamponade | 2/1024 (0.2%) | 2/477 (0.4%) | ||
| Cardio-respiratory arrest | 0/1024 (0%) | 1/477 (0.2%) | ||
| Cardiomyopathy | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Cardiopulmonary failure | 0/1024 (0%) | 1/477 (0.2%) | ||
| Coronary artery disease | 1/1024 (0.1%) | 0/477 (0%) | ||
| Coronary artery occlusion | 1/1024 (0.1%) | 0/477 (0%) | ||
| Coronary artery stenosis | 1/1024 (0.1%) | 0/477 (0%) | ||
| Left ventricular failure | 1/1024 (0.1%) | 0/477 (0%) | ||
| Myocardial infarction | 3/1024 (0.3%) | 1/477 (0.2%) | ||
| Myocardial ischaemia | 2/1024 (0.2%) | 0/477 (0%) | ||
| Palpitations | 1/1024 (0.1%) | 0/477 (0%) | ||
| Pericardial effusion | 3/1024 (0.3%) | 1/477 (0.2%) | ||
| Pericarditis | 2/1024 (0.2%) | 0/477 (0%) | ||
| Sick sinus syndrome | 0/1024 (0%) | 2/477 (0.4%) | ||
| Supraventricular tachycardia | 1/1024 (0.1%) | 0/477 (0%) | ||
| Tachycardia | 2/1024 (0.2%) | 0/477 (0%) | ||
| Ventricular fibrillation | 0/1024 (0%) | 1/477 (0.2%) | ||
| Ventricular tachycardia | 2/1024 (0.2%) | 0/477 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 3/1024 (0.3%) | 2/477 (0.4%) | ||
| Endocrine disorders | ||||
| Adrenal insufficiency | 2/1024 (0.2%) | 0/477 (0%) | ||
| Hypothyroidism | 1/1024 (0.1%) | 0/477 (0%) | ||
| Eye disorders | ||||
| Retinal vascular thrombosis | 0/1024 (0%) | 1/477 (0.2%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 0/1024 (0%) | 2/477 (0.4%) | ||
| Abdominal pain lower | 0/1024 (0%) | 1/477 (0.2%) | ||
| Abdominal pain upper | 1/1024 (0.1%) | 0/477 (0%) | ||
| Aphagia | 1/1024 (0.1%) | 0/477 (0%) | ||
| Colitis | 0/1024 (0%) | 1/477 (0.2%) | ||
| Constipation | 1/1024 (0.1%) | 0/477 (0%) | ||
| Diarrhoea | 0/1024 (0%) | 1/477 (0.2%) | ||
| Diverticulum intestinal | 1/1024 (0.1%) | 0/477 (0%) | ||
| Duodenal ulcer | 1/1024 (0.1%) | 0/477 (0%) | ||
| Duodenitis | 1/1024 (0.1%) | 0/477 (0%) | ||
| Dyspepsia | 0/1024 (0%) | 1/477 (0.2%) | ||
| Dysphagia | 4/1024 (0.4%) | 0/477 (0%) | ||
| Gastritis | 1/1024 (0.1%) | 0/477 (0%) | ||
| Gastritis erosive | 0/1024 (0%) | 2/477 (0.4%) | ||
| Haemorrhoidal haemorrhage | 0/1024 (0%) | 1/477 (0.2%) | ||
| Hernial eventration | 0/1024 (0%) | 1/477 (0.2%) | ||
| Ileus | 1/1024 (0.1%) | 0/477 (0%) | ||
| Inguinal hernia | 0/1024 (0%) | 2/477 (0.4%) | ||
| Intestinal infarction | 1/1024 (0.1%) | 0/477 (0%) | ||
| Lower gastrointestinal haemorrhage | 1/1024 (0.1%) | 0/477 (0%) | ||
| Oesophageal dilatation | 1/1024 (0.1%) | 0/477 (0%) | ||
| Oesophageal obstruction | 2/1024 (0.2%) | 0/477 (0%) | ||
| Oesophageal stenosis | 2/1024 (0.2%) | 0/477 (0%) | ||
| Pancreatitis | 1/1024 (0.1%) | 0/477 (0%) | ||
| Pancreatitis chronic | 1/1024 (0.1%) | 0/477 (0%) | ||
| Vomiting | 1/1024 (0.1%) | 3/477 (0.6%) | ||
| General disorders | ||||
| Asthenia | 2/1024 (0.2%) | 3/477 (0.6%) | ||
| Chest discomfort | 0/1024 (0%) | 1/477 (0.2%) | ||
| Chest pain | 9/1024 (0.9%) | 3/477 (0.6%) | ||
| Death | 2/1024 (0.2%) | 0/477 (0%) | ||
| Disease progression | 6/1024 (0.6%) | 11/477 (2.3%) | ||
| Fatigue | 3/1024 (0.3%) | 0/477 (0%) | ||
| Gait disturbance | 1/1024 (0.1%) | 0/477 (0%) | ||
| General physical health deterioration | 2/1024 (0.2%) | 3/477 (0.6%) | ||
| Malaise | 1/1024 (0.1%) | 0/477 (0%) | ||
| Non-cardiac chest pain | 4/1024 (0.4%) | 1/477 (0.2%) | ||
| Pain | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Performance status decreased | 0/1024 (0%) | 1/477 (0.2%) | ||
| Pyrexia | 8/1024 (0.8%) | 0/477 (0%) | ||
| Spinal pain | 1/1024 (0.1%) | 0/477 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis acute | 1/1024 (0.1%) | 0/477 (0%) | ||
| Hepatic failure | 1/1024 (0.1%) | 0/477 (0%) | ||
| Hepatitis alcoholic | 1/1024 (0.1%) | 0/477 (0%) | ||
| Hyperbilirubinaemia | 0/1024 (0%) | 1/477 (0.2%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 1/1024 (0.1%) | 0/477 (0%) | ||
| Infections and infestations | ||||
| Appendicitis | 0/1024 (0%) | 1/477 (0.2%) | ||
| Bronchitis | 4/1024 (0.4%) | 1/477 (0.2%) | ||
| Bronchopneumonia | 1/1024 (0.1%) | 0/477 (0%) | ||
| Bronchopulmonary aspergillosis | 1/1024 (0.1%) | 0/477 (0%) | ||
| Cellulitis | 1/1024 (0.1%) | 0/477 (0%) | ||
| Device related infection | 1/1024 (0.1%) | 0/477 (0%) | ||
| Empyema | 0/1024 (0%) | 1/477 (0.2%) | ||
| Gastroenteritis | 1/1024 (0.1%) | 0/477 (0%) | ||
| Helicobacter gastritis | 1/1024 (0.1%) | 0/477 (0%) | ||
| Herpes zoster disseminated | 1/1024 (0.1%) | 0/477 (0%) | ||
| Infectious pleural effusion | 1/1024 (0.1%) | 0/477 (0%) | ||
| Influenza | 0/1024 (0%) | 1/477 (0.2%) | ||
| Lobar pneumonia | 1/1024 (0.1%) | 0/477 (0%) | ||
| Lower respiratory tract infection | 9/1024 (0.9%) | 4/477 (0.8%) | ||
| Lung abscess | 1/1024 (0.1%) | 0/477 (0%) | ||
| Lung infection | 4/1024 (0.4%) | 0/477 (0%) | ||
| Mastitis | 0/1024 (0%) | 1/477 (0.2%) | ||
| Nasopharyngitis | 1/1024 (0.1%) | 0/477 (0%) | ||
| Pleural infection | 1/1024 (0.1%) | 0/477 (0%) | ||
| Pneumonia | 30/1024 (2.9%) | 14/477 (2.9%) | ||
| Pneumonia primary atypical | 1/1024 (0.1%) | 0/477 (0%) | ||
| Respiratory tract infection | 7/1024 (0.7%) | 2/477 (0.4%) | ||
| Salmonella sepsis | 0/1024 (0%) | 1/477 (0.2%) | ||
| Septic shock | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Upper respiratory tract infection | 2/1024 (0.2%) | 0/477 (0%) | ||
| Viral upper respiratory tract infection | 0/1024 (0%) | 1/477 (0.2%) | ||
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 1/1024 (0.1%) | 0/477 (0%) | ||
| Cervical vertebral fracture | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Clavicle fracture | 0/1024 (0%) | 1/477 (0.2%) | ||
| Concussion | 1/1024 (0.1%) | 0/477 (0%) | ||
| Craniocerebral injury | 0/1024 (0%) | 1/477 (0.2%) | ||
| Fall | 0/1024 (0%) | 1/477 (0.2%) | ||
| Femoral neck fracture | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Femur fracture | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Foot fracture | 2/1024 (0.2%) | 0/477 (0%) | ||
| Hip fracture | 0/1024 (0%) | 1/477 (0.2%) | ||
| Humerus fracture | 1/1024 (0.1%) | 0/477 (0%) | ||
| Laceration | 1/1024 (0.1%) | 0/477 (0%) | ||
| Lower limb fracture | 1/1024 (0.1%) | 0/477 (0%) | ||
| Lumbar vertebral fracture | 0/1024 (0%) | 1/477 (0.2%) | ||
| Meniscus lesion | 0/1024 (0%) | 1/477 (0.2%) | ||
| Overdose | 1/1024 (0.1%) | 0/477 (0%) | ||
| Procedural complication | 1/1024 (0.1%) | 0/477 (0%) | ||
| Procedural pain | 1/1024 (0.1%) | 0/477 (0%) | ||
| Radiation associated pain | 1/1024 (0.1%) | 0/477 (0%) | ||
| Radiation myelopathy | 0/1024 (0%) | 1/477 (0.2%) | ||
| Radiation pneumonitis | 7/1024 (0.7%) | 5/477 (1%) | ||
| Rib fracture | 1/1024 (0.1%) | 0/477 (0%) | ||
| Road traffic accident | 1/1024 (0.1%) | 0/477 (0%) | ||
| Spinal compression fracture | 1/1024 (0.1%) | 0/477 (0%) | ||
| Thoracic vertebral fracture | 1/1024 (0.1%) | 0/477 (0%) | ||
| Traumatic lung injury | 1/1024 (0.1%) | 0/477 (0%) | ||
| Vascular pseudoaneurysm | 1/1024 (0.1%) | 0/477 (0%) | ||
| Wound evisceration | 1/1024 (0.1%) | 0/477 (0%) | ||
| Investigations | ||||
| Weight decreased | 1/1024 (0.1%) | 0/477 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 2/1024 (0.2%) | 0/477 (0%) | ||
| Dehydration | 4/1024 (0.4%) | 1/477 (0.2%) | ||
| Diabetes mellitus inadequate control | 1/1024 (0.1%) | 0/477 (0%) | ||
| Hypercalcaemia | 0/1024 (0%) | 2/477 (0.4%) | ||
| Hyperkalaemia | 0/1024 (0%) | 1/477 (0.2%) | ||
| Hyponatraemia | 0/1024 (0%) | 1/477 (0.2%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 0/1024 (0%) | 2/477 (0.4%) | ||
| Arthritis | 1/1024 (0.1%) | 0/477 (0%) | ||
| Back pain | 1/1024 (0.1%) | 2/477 (0.4%) | ||
| Bone pain | 1/1024 (0.1%) | 0/477 (0%) | ||
| Muscle atrophy | 1/1024 (0.1%) | 0/477 (0%) | ||
| Muscular weakness | 0/1024 (0%) | 1/477 (0.2%) | ||
| Musculoskeletal pain | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Pain in extremity | 2/1024 (0.2%) | 1/477 (0.2%) | ||
| Pathological fracture | 1/1024 (0.1%) | 0/477 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Basal cell carcinoma | 2/1024 (0.2%) | 2/477 (0.4%) | ||
| Bile duct cancer | 1/1024 (0.1%) | 0/477 (0%) | ||
| Bladder cancer | 1/1024 (0.1%) | 2/477 (0.4%) | ||
| Breast cancer | 1/1024 (0.1%) | 0/477 (0%) | ||
| Colon cancer | 1/1024 (0.1%) | 0/477 (0%) | ||
| Gastric cancer | 1/1024 (0.1%) | 0/477 (0%) | ||
| Lung cancer metastatic | 1/1024 (0.1%) | 0/477 (0%) | ||
| Malignant pleural effusion | 0/1024 (0%) | 1/477 (0.2%) | ||
| Meningioma | 1/1024 (0.1%) | 0/477 (0%) | ||
| Metastases to bone | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Metastases to central nervous system | 32/1024 (3.1%) | 9/477 (1.9%) | ||
| Metastases to kidney | 2/1024 (0.2%) | 1/477 (0.2%) | ||
| Metastases to large intestine | 1/1024 (0.1%) | 0/477 (0%) | ||
| Metastases to lung | 1/1024 (0.1%) | 0/477 (0%) | ||
| Metastases to lymph nodes | 1/1024 (0.1%) | 0/477 (0%) | ||
| Metastases to pancreas | 1/1024 (0.1%) | 0/477 (0%) | ||
| Metastases to salivary gland | 1/1024 (0.1%) | 0/477 (0%) | ||
| Metastases to small intestine | 1/1024 (0.1%) | 0/477 (0%) | ||
| Oncologic complication | 1/1024 (0.1%) | 0/477 (0%) | ||
| Paraneoplastic syndrome | 0/1024 (0%) | 1/477 (0.2%) | ||
| Prostate cancer | 1/1024 (0.1%) | 0/477 (0%) | ||
| Prostatic adenoma | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Renal cell carcinoma | 0/1024 (0%) | 1/477 (0.2%) | ||
| Thyroid neoplasm | 0/1024 (0%) | 1/477 (0.2%) | ||
| Tonsil cancer | 1/1024 (0.1%) | 0/477 (0%) | ||
| Tumour invasion | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Tumour pain | 1/1024 (0.1%) | 0/477 (0%) | ||
| Nervous system disorders | ||||
| Altered state of consciousness | 1/1024 (0.1%) | 0/477 (0%) | ||
| Aphasia | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Balance disorder | 1/1024 (0.1%) | 0/477 (0%) | ||
| Brain oedema | 1/1024 (0.1%) | 0/477 (0%) | ||
| Carotid artery dissection | 1/1024 (0.1%) | 0/477 (0%) | ||
| Carotid artery occlusion | 1/1024 (0.1%) | 0/477 (0%) | ||
| Cataplexy | 0/1024 (0%) | 1/477 (0.2%) | ||
| Cerebral ischaemia | 0/1024 (0%) | 2/477 (0.4%) | ||
| Cerebrovascular accident | 0/1024 (0%) | 2/477 (0.4%) | ||
| Convulsion | 4/1024 (0.4%) | 2/477 (0.4%) | ||
| Dizziness | 4/1024 (0.4%) | 0/477 (0%) | ||
| Epilepsy | 2/1024 (0.2%) | 2/477 (0.4%) | ||
| Grand mal convulsion | 1/1024 (0.1%) | 0/477 (0%) | ||
| Guillain-Barre syndrome | 1/1024 (0.1%) | 0/477 (0%) | ||
| Haemorrhage intracranial | 1/1024 (0.1%) | 0/477 (0%) | ||
| Headache | 3/1024 (0.3%) | 0/477 (0%) | ||
| Hemiparesis | 4/1024 (0.4%) | 0/477 (0%) | ||
| Ischaemic cerebral infarction | 1/1024 (0.1%) | 0/477 (0%) | ||
| Ischaemic stroke | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Monoparesis | 1/1024 (0.1%) | 0/477 (0%) | ||
| Nerve root compression | 1/1024 (0.1%) | 0/477 (0%) | ||
| Paraplegia | 1/1024 (0.1%) | 0/477 (0%) | ||
| Partial seizures | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Peripheral motor neuropathy | 0/1024 (0%) | 1/477 (0.2%) | ||
| Somnolence | 0/1024 (0%) | 1/477 (0.2%) | ||
| Spinal cord compression | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Status epilepticus | 0/1024 (0%) | 1/477 (0.2%) | ||
| Syncope | 4/1024 (0.4%) | 1/477 (0.2%) | ||
| Transient ischaemic attack | 2/1024 (0.2%) | 0/477 (0%) | ||
| Tremor | 0/1024 (0%) | 1/477 (0.2%) | ||
| Psychiatric disorders | ||||
| Anxiety | 0/1024 (0%) | 1/477 (0.2%) | ||
| Completed suicide | 1/1024 (0.1%) | 0/477 (0%) | ||
| Confusional state | 3/1024 (0.3%) | 1/477 (0.2%) | ||
| Depression | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Mental status changes | 0/1024 (0%) | 1/477 (0.2%) | ||
| Suicide attempt | 2/1024 (0.2%) | 0/477 (0%) | ||
| Renal and urinary disorders | ||||
| Haematuria | 1/1024 (0.1%) | 0/477 (0%) | ||
| Urinary retention | 1/1024 (0.1%) | 0/477 (0%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 1/1024 (0.1%) | 0/477 (0%) | ||
| Ovarian cyst | 0/1024 (0%) | 1/477 (0.2%) | ||
| Spermatocele | 1/1024 (0.1%) | 0/477 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory failure | 2/1024 (0.2%) | 0/477 (0%) | ||
| Atelectasis | 2/1024 (0.2%) | 0/477 (0%) | ||
| Bronchial haemorrhage | 0/1024 (0%) | 1/477 (0.2%) | ||
| Bronchial obstruction | 0/1024 (0%) | 1/477 (0.2%) | ||
| Bronchitis chronic | 1/1024 (0.1%) | 0/477 (0%) | ||
| Bronchostenosis | 1/1024 (0.1%) | 0/477 (0%) | ||
| Chronic obstructive pulmonary disease | 3/1024 (0.3%) | 7/477 (1.5%) | ||
| Cough | 3/1024 (0.3%) | 1/477 (0.2%) | ||
| Dysphonia | 1/1024 (0.1%) | 0/477 (0%) | ||
| Dyspnoea | 29/1024 (2.8%) | 13/477 (2.7%) | ||
| Epistaxis | 2/1024 (0.2%) | 0/477 (0%) | ||
| Haemoptysis | 11/1024 (1.1%) | 5/477 (1%) | ||
| Hypoxia | 2/1024 (0.2%) | 0/477 (0%) | ||
| Laryngeal cyst | 1/1024 (0.1%) | 0/477 (0%) | ||
| Lung infiltration | 1/1024 (0.1%) | 0/477 (0%) | ||
| Oesophagobronchial fistula | 1/1024 (0.1%) | 0/477 (0%) | ||
| Pleural effusion | 13/1024 (1.3%) | 12/477 (2.5%) | ||
| Pleurisy | 1/1024 (0.1%) | 2/477 (0.4%) | ||
| Pneumonitis | 2/1024 (0.2%) | 1/477 (0.2%) | ||
| Pneumothorax | 6/1024 (0.6%) | 1/477 (0.2%) | ||
| Pulmonary embolism | 10/1024 (1%) | 2/477 (0.4%) | ||
| Pulmonary haemorrhage | 8/1024 (0.8%) | 4/477 (0.8%) | ||
| Pulmonary hypertension | 1/1024 (0.1%) | 0/477 (0%) | ||
| Pulmonary oedema | 0/1024 (0%) | 1/477 (0.2%) | ||
| Respiratory failure | 0/1024 (0%) | 4/477 (0.8%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 1/1024 (0.1%) | 1/477 (0.2%) | ||
| Surgical and medical procedures | ||||
| Pericardial drainage | 1/1024 (0.1%) | 0/477 (0%) | ||
| Vascular disorders | ||||
| Aortic aneurysm | 5/1024 (0.5%) | 1/477 (0.2%) | ||
| Aortic stenosis | 0/1024 (0%) | 1/477 (0.2%) | ||
| Arterial occlusive disease | 1/1024 (0.1%) | 0/477 (0%) | ||
| Deep vein thrombosis | 0/1024 (0%) | 1/477 (0.2%) | ||
| Embolism | 1/1024 (0.1%) | 0/477 (0%) | ||
| Femoral arterial stenosis | 1/1024 (0.1%) | 0/477 (0%) | ||
| Hypotension | 2/1024 (0.2%) | 0/477 (0%) | ||
| Orthostatic hypotension | 0/1024 (0%) | 1/477 (0.2%) | ||
| Peripheral arterial occlusive disease | 1/1024 (0.1%) | 0/477 (0%) | ||
| Peripheral artery aneurysm | 1/1024 (0.1%) | 0/477 (0%) | ||
| Peripheral vascular disorder | 0/1024 (0%) | 1/477 (0.2%) | ||
| Temporal arteritis | 0/1024 (0%) | 1/477 (0.2%) | ||
| Thrombosis | 0/1024 (0%) | 1/477 (0.2%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Tecemotide (L-BLP25) + Cyclophosphamide | Saline + Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 918/1024 (89.6%) | 417/477 (87.4%) | ||
| Gastrointestinal disorders | ||||
| Constipation | 75/1024 (7.3%) | 26/477 (5.5%) | ||
| Diarrhoea | 85/1024 (8.3%) | 46/477 (9.6%) | ||
| Nausea | 140/1024 (13.7%) | 39/477 (8.2%) | ||
| Vomiting | 65/1024 (6.3%) | 26/477 (5.5%) | ||
| General disorders | ||||
| Asthenia | 71/1024 (6.9%) | 29/477 (6.1%) | ||
| Chest pain | 130/1024 (12.7%) | 43/477 (9%) | ||
| Fatigue | 195/1024 (19%) | 102/477 (21.4%) | ||
| Influenza like illness | 45/1024 (4.4%) | 27/477 (5.7%) | ||
| Non-cardiac chest pain | 57/1024 (5.6%) | 24/477 (5%) | ||
| Pyrexia | 80/1024 (7.8%) | 41/477 (8.6%) | ||
| Infections and infestations | ||||
| Bronchitis | 83/1024 (8.1%) | 38/477 (8%) | ||
| Nasopharyngitis | 128/1024 (12.5%) | 44/477 (9.2%) | ||
| Upper respiratory tract infection | 96/1024 (9.4%) | 37/477 (7.8%) | ||
| Injury, poisoning and procedural complications | ||||
| Radiation pneumonitis | 77/1024 (7.5%) | 30/477 (6.3%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 109/1024 (10.6%) | 44/477 (9.2%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 108/1024 (10.5%) | 33/477 (6.9%) | ||
| Back pain | 146/1024 (14.3%) | 52/477 (10.9%) | ||
| Musculoskeletal chest pain | 54/1024 (5.3%) | 22/477 (4.6%) | ||
| Musculoskeletal pain | 92/1024 (9%) | 33/477 (6.9%) | ||
| Myalgia | 73/1024 (7.1%) | 18/477 (3.8%) | ||
| Pain in extremity | 69/1024 (6.7%) | 29/477 (6.1%) | ||
| Nervous system disorders | ||||
| Dizziness | 87/1024 (8.5%) | 37/477 (7.8%) | ||
| Headache | 123/1024 (12%) | 54/477 (11.3%) | ||
| Psychiatric disorders | ||||
| Insomnia | 64/1024 (6.3%) | 25/477 (5.2%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 336/1024 (32.8%) | 133/477 (27.9%) | ||
| Dyspnoea | 225/1024 (22%) | 103/477 (21.6%) | ||
| Haemoptysis | 60/1024 (5.9%) | 32/477 (6.7%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 53/1024 (5.2%) | 27/477 (5.7%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
After conclusion of the study, an integrated clinical and statistical study report shall be written by the Sponsor in consultation with the Coordinating Investigator based on the protocol. The first publication will be a full publication of all data from all sites. The Sponsor is entitled to delay publication in order to obtain patent protection. The ICMJE criteria for authorship will be followed. A separate publication plan will be set up to describe further publications.
Results Point of Contact
| Name/Title | Merck KGaA Communication Center |
|---|---|
| Organization | Merck Serono, a division of Merck KGaA |
| Phone | +49-6151-72-5200 |
| service@merckgroup.com |
Responsible Party:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00409188
Other Study ID Numbers:
- EMR 63325-001
First Posted:
Dec 8, 2006
Last Update Posted:
Nov 20, 2015
Last Verified:
Oct 1, 2015