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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab Arm | Experimental | Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
|
| Active Comparator Arm （Docetaxel/Paclitaxel） | Active Comparator | Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug |
| ||
| Docetaxel/Paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | ("Date of death from any cause" - "Date of randomization" + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)." | ("Earlier date on which either the overall response was assessed as PD or the subject died of any cause" - "Date of randomization" + 1) / 30.4375. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ono Pharmaceutical Co., Ltd. Ono Pharmaceutical Co., Ltd. | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Georgetown University Med Ctr |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31582355 | Derived | Kato K, Cho BC, Takahashi M, Okada M, Lin CY, Chin K, Kadowaki S, Ahn MJ, Hamamoto Y, Doki Y, Yen CC, Kubota Y, Kim SB, Hsu CH, Holtved E, Xynos I, Kodani M, Kitagawa Y. Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Nov;20(11):1506-1517. doi: 10.1016/S1470-2045(19)30626-6. Epub 2019 Sep 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab Arm | Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
| FG001 | Active Comparator Arm （Docetaxel/Paclitaxel） |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2017 |
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|
| Duration of Response | Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)." | ("Earlier date on which either the overall response was assessed as PD for the first time after confirmed response or the subject died of any cause" - "Date of first assessment of confirmed CR or PR" + 1) / 30.4375. |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Orlando Health, Inc | Orlando | Florida | 32806 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| Vanderbilt-Ingram Cancer Ctr | Nashville | Tennessee | 37232 | United States |
| The University Of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Odense University Hospital | Odense C | 5000 | Denmark |
| RWTH Aachen University | Aachen | 52057 | Germany |
| Charite Campus Virchow Klinikum | Berlin | D-13353 | Germany |
| University Hospital Heidelberg | Heidelberg | 69120 | Germany |
| Universitatsklinikum Jena, Innere Medizin II | Jena | 07747 | Germany |
| MVZ Mitte | Leipzig | 04103 | Germany |
| University Of Mainz Medical Center | Mainz | 55131 | Germany |
| Klinikum reechts der Isar, Technical University Munchen | Munich | 81675 | Germany |
| HPG23 | Bergamo | 24127 | Italy |
| Fondazione Irccs Istituto Nazionale Tumori | Milan | 20133 | Italy |
| Irccs Istituto Oncologico Veneto Iov | Padova | 35128 | Italy |
| Aichi Clinical Site | Nagoya | Aichi-ken | 464-8681 | Japan |
| Aichi Clinical Site | Nagoya | Aichi-ken | 466-8560 | Japan |
| Aomori Clinical Site | Hirosaki | Aomori | 036-8563 | Japan |
| Chiba Clinical Site | Kashiwa | Chiba | 277-8577 | Japan |
| Ehime Clinical Site | Matsuyama | Ehime | 791-0288 | Japan |
| Hokkaido Clinical Site | Sapporo | Hokkaido | 003-0027 | Japan |
| Hokkaido Clinical Site | Sapporo | Hokkaido | 060-8648 | Japan |
| Hyogo Clinical Site | Akashi | Hyōgo | 673-0021 | Japan |
| Hyogo Clinical Site | Kobe | Hyōgo | 650-0047 | Japan |
| Kanagawa Clinical Site | Isehara | Kanagawa | 259-1193 | Japan |
| Kanagawa Clinical Site | Kawasaki | Kanagawa | 216-0015 | Japan |
| Kanagawa Clinical Site | Yokohama | Kanagawa | 236-0004 | Japan |
| Kanagawa Clinical Site | Yokohama | Kanagawa | 241-8515 | Japan |
| Mie Clinical Site | Tsu | Mie-ken | 514-8507 | Japan |
| Miyagi Clinical Site | Sendai | Miyagi | 980-8574 | Japan |
| Nagano Clinical Site | Saku | Nagano | 385-0051 | Japan |
| Niigata Clinical Site | Nigatake | Niigata | 951-8520 | Japan |
| Osaka Clinical Site | Sayama | Osaka | 589-8511 | Japan |
| Osaka Clinical Site | Suita | Osaka | 565-0871 | Japan |
| Osaka Clinical Site | Takatsuki | Osaka | 569-0801 | Japan |
| Saitama Clinical Site | Hidaka | Saitama | 350-1298 | Japan |
| Saitama Clinical Site | Kita-Adachi County | Saitama | 362-0806 | Japan |
| Shizuoka Clinical Site | Suntou County | Shizuoka | 411-8777 | Japan |
| Tochigi Clinical Site | Shimotsuke | Tochigi | 329-0431 | Japan |
| Tokyo Clinical Site | Bunkyo-ku | Tokyo | 113-0021 | Japan |
| Tokyo Clinical Site | Chuo-ku | Tokyo | 104-0045 | Japan |
| Tokyo Clinical Site | Chuo-ku | Tokyo | 104-8560 | Japan |
| Tokyo Clinical Site | Koto-ku | Tokyo | 135-8550 | Japan |
| Tokyo Clinical Site | Meguro-ku | Tokyo | 152-8902 | Japan |
| Tokyo Clinical Site | Minato-ku | Tokyo | 105-8470 | Japan |
| Tokyo Clinical Site | Shinagawa-ku | Tokyo | 142-8666 | Japan |
| Tokyo Clinical Site | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Tokyo Clinical Site | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Akita Clinical Site | Akita | 010-8543 | Japan |
| Chiba Clinical Site | Chiba | 260-0801 | Japan |
| Chiba Clinical Site | Chiba | 260-8677 | Japan |
| Fukuoka Clinical Site | Fukuoka | 812-8582 | Japan |
| Fukushima Clinical Site | Fukushima | 960-1295 | Japan |
| Hiroshima Clinical Site | Hiroshima | 734-8551 | Japan |
| Kagoshima Clinical Site | Kagoshima | 890-8520 | Japan |
| Kumamoto Clinical Site | Kumamoto | 860-8556 | Japan |
| Kyoto Clinical Site | Kyoto | 602-8566 | Japan |
| Kyoto Clinical Site | Kyoto | 606-8507 | Japan |
| Niigata Clinical Site | Niigata | 951-8566 | Japan |
| Osaka Clinical Site | Osaka | 537-8511 | Japan |
| Shizuoka Clinical Site | Shizuoka | 420-8527 | Japan |
| Busan Clinical Site | Busan | 49241 | South Korea |
| Daegu Clinical Site | Daegu | 41404 | South Korea |
| Daegu Clinical Site | Daegu | 41931 | South Korea |
| Daejeon Clinical Site | Daejeon | 35015 | South Korea |
| Gyeonggi-do Clinical Site | Gyeonggi-do | 13620 | South Korea |
| Hwasun-Gun Clinical Site | Hwasun-Gun | 58128 | South Korea |
| Seoul Clinical Site | Seoul | 03080 | South Korea |
| Seoul Clinical Site | Seoul | 03722 | South Korea |
| Seoul Clinical Site | Seoul | 05505 | South Korea |
| Seoul Clinical Site | Seoul | 06351 | South Korea |
| Seoul Clinical Site | Seoul | 06591 | South Korea |
| Ulsan Clinical Site | Ulsan | 44033 | South Korea |
| Changhua Clinical Site | Changhua | 500 | Taiwan |
| Chiayi Clinical Site | Chiayi City | 61363 | Taiwan |
| Kaohsiung Clinical Site | Kaohsiung City | 807 | Taiwan |
| Kaohsiung Clinical Site | Kaohsiung City | 82445 | Taiwan |
| Kaohsiung Clinical Site | Kaohsiung City | 83301 | Taiwan |
| Keelung Clinical Site | Keelung | 20445 | Taiwan |
| Taichung Clinical Site | Taichung | 40447 | Taiwan |
| Tainan Clinical Site | Tainan | 704 | Taiwan |
| Taipei Clinical Site | Taipei | 10048 | Taiwan |
| Taipei Clinical Site | Taipei | 11217 | Taiwan |
| Taoyuan Clinical Site | Taoyuan | 333 | Taiwan |
| Velindre Cancer Centre | Cardiff | Cardiganshire | CF142TL | United Kingdom |
| The Beatson West Of Scotland Cancer Centre | Glasgow | Lanarkshire | G12 0YN | United Kingdom |
Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
|
| COMPLETED | Received assigned treatment of IMP |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab Arm | Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
| BG001 | Active Comparator Arm （Docetaxel/Paclitaxel） | Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| ECOG performance status | performance status 0；Fully active, able to continue all pre-disease activities without restriction performance status 1；Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work | Count of Participants | Participants |
| |||||||||||||||
| Disease stage : TNM classification | In this study, the TNM Classification of Malignant Tumours, Seventh Edition, published by the Union for International Cancer Control (UICC) (hereinafter referred to as "the TNM classification") will be used to determine disease stage. please refer to the protocol information. Higher numbers mean the cancer is more advanced. | Summarized for subjects with non-recurrent esophageal cancer. | Count of Participants | Participants |
| ||||||||||||||
| Previous therapies | Count of Participants | Participants |
| ||||||||||||||||
| Number of organs of metastases | Count of Participants | Participants |
| ||||||||||||||||
| Site of metastases | Count of Participants | Participants |
| ||||||||||||||||
| PD-L1 expression | In this study, the subject will test positive for PD-L1 when cancerous cells with stained cell membranes account for ≧1% of at least 100 evaluable cancerous cells and will test negative for PD-L1 when such cells account for <1%, the same applies to 5% and 10%. | Count of Participants | Participants |
| |||||||||||||||
| History of smoking | 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 | Overall Survival | Posted | Median | 95% Confidence Interval | months | ("Date of death from any cause" - "Date of randomization" + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive. |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)." | Posted | Median | 95% Confidence Interval | months | ("Earlier date on which either the overall response was assessed as PD or the subject died of any cause" - "Date of randomization" + 1) / 30.4375. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)." | Posted | Median | 95% Confidence Interval | months | ("Earlier date on which either the overall response was assessed as PD for the first time after confirmed response or the subject died of any cause" - "Date of first assessment of confirmed CR or PR" + 1) / 30.4375. |
|
Monitoring for any AEs will be continued until 28 days after the end of the treatment phase. In subjects who, at the time of initiation of the follow-up investigation, have any AE for which a causal relationship to the investigational product cannot be ruled out or which led to discontinuation, investigation of the AE will be continued until the event is judged not to require further follow-up. SAEs are to be collected during the treatment period and for 100 days following the last dose.
For all-cause mortality, the number of adverse events reported as Grade 5 was extracted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nivolumab Arm | Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends | 7 | 209 | 68 | 209 | 185 | 209 |
| EG001 | Active Comparator Arm （Docetaxel/Paclitaxel） | Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends | 5 | 208 | 77 | 208 | 204 | 208 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Tracheo-oesophageal fistula | Congenital, familial and genetic disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Adrenocorticotropic hormone deficiency | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastric fistula | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Aorto-oesophageal fistula | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Stenosis | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Mediastinitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Spinal cord abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Stoma site extravasation | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oesophagobronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Tracheal fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Jejunostomy | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Center | Ono Pharmaceutical Co. Ltd | ー | clinical_trial@ono.co.jp |
| Oct 18, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
|
| White |
|
|
|
| 1 |
|
|
|
| IV |
|
|
| unknown |
|
|
|
| Radiothrapy |
|
|
| Systemic anticancer therapy |
|
|
|
| >=2 |
|
|
|
| Liver |
|
|
| Lung |
|
|
| Bone |
|
|
|
| >=1% |
|
|
| <5% |
|
|
| >=5% |
|
|
| <10% |
|
|
| >=10% |
|
|
|
| Former |
|
|
| Current |
|
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|