Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT # : 2005-005464-92 |
Not provided
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This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population.
Primary objective:
Secondary objectives:
The purpose of this study (Part II) was to evaluate the time to progression in the 3 arms at an optimal dose level of docetaxel and oxaliplatin defined during a prior pilot (Part I) phase study. The estimated duration of treatment was to be 6 months. Treatment was to be administered up to progression, unacceptable toxicities, or withdrawal of consent. The reason and date of removal of all participants was documented on the case report form.
Participants who ended treatment but had not yet progressed (e.g. unacceptable toxicities or withdrawal of consent) were be followed every 8 weeks with a complete tumor assessment until documented progression or further anti-tumor therapy. Then, they would be followed every 3 months after progression for survival status; date of death or progression were reported. Participants who ended treatment for progression, were to be followed every 3 months until death. Date of death was reported. The planned duration of the study was 30 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TE (Taxotere and Eloxatin) | Experimental | Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin). Each chemotherapy cycle was repeated every 21 days. Participants received either the optimal or non-optimal dose for Taxotere and Eloxatin. Participants who received the optimal dose for Taxotere and Eloxatin were analyzed in this study. |
|
| TEF (Taxotere, Eloxatin and 5-FU) | Experimental | Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and 5-FU (5-Fluorouracil). Each chemotherapy cycle was repeated every 14 days. Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and 5-FU. Participants who received the optimal dose for Taxotere, Eloxatin and 5-FU were analyzed in this study. |
|
| TEX (Taxotere, Eloxatin and Xeloda) | Experimental | Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and capecitabine (Xeloda). Each chemotherapy cycle was repeated every 21 days. Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and Xeloda. Participants who received the optimal dose for Taxotere, Eloxatin and Xeloda were analyzed in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel + Oxaliplatin | Drug | Dose level 1 (non-optimal dose): Docetaxel 75 mg/m² as an 1-hour intravenous (IV) infusion on day 1 followed by Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1 Dose level 2 (optimal dose): Docetaxel 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin 130 mg/m² as a two to six-hour IV infusion on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause. WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion. | every 8 weeks up to a maximum of 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response Rate (ORR) | Percentage of partial and complete responses, according to WHO criteria: Complete Response: Disappearance of all known disease, determined by 2 observations not less than 4 weeks apart. Partial Response: Decrease by at least 50% of the diameters of all measurable lesions, determined by 2 observations not less than 4 weeks apart. | every 8 weeks up to a maximum of 36 months |
Not provided
Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe Aussel | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | United States | |||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25416687 | Derived | Van Cutsem E, Boni C, Tabernero J, Massuti B, Middleton G, Dane F, Reichardt P, Pimentel FL, Cohn A, Follana P, Clemens M, Zaniboni A, Moiseyenko V, Harrison M, Richards DA, Prenen H, Pernot S, Ecstein-Fraisse E, Hitier S, Rougier P. Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: a randomized phase II study. Ann Oncol. 2015 Jan;26(1):149-156. doi: 10.1093/annonc/mdu496. |
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The intent-to-treat (ITT) population, included 254 participants randomized to the optimal dose of study medication from Parts I (43) and II (211), and excluded 21 participants administered the non-optimal dose in Part I.
A total 275 participants from 12 countries were randomized in the part I/II study. 64 participants were enrolled in Part I. 211 new participants were enrolled specifically for Part II.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | (TE) Taxotere and Eloxatin | Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle. |
| FG001 | (TEF) Taxotere, Eloxatin and 5-fluorouracil | Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle. |
| FG002 | (TEX) Taxotere, Eloxatin and Xeloda | Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | (TE) Taxotere and Eloxatin | Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle. |
| BG001 | (TEF) Taxotere, Eloxatin and 5-fluorouracil |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Time to Progression | The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause. WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion. | 248 participants in the full analysis population (FAP). | Posted | Median | 95% Confidence Interval | Months | every 8 weeks up to a maximum of 36 months |
|
Not provided
248 participants in the full analysis population (FAP) were analyzed for safety.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | (TE) Taxotere and Eloxatin | Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| International Clinical Development Clinical Study Director | sanofi-aventis | contact-us@sanofi-aventis.com |
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Docetaxel + Oxaliplatin + 5-FU | Drug | Dose level 1 (non-optimal dose): Docetaxel 40 mg/m² as a 1-hour intravenous (IV) infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m2 as a 46-hour continuous infusion day 1. Dose level 2 (optimal dose): Docetaxel 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1. |
|
| Docetaxel + Oxaliplatin + Capecitabine | Drug | Dose level 1 (optimal dose): Docetaxel 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m2 two times a day continuously. Dose level 2 (non-optimal dose): Docetaxel 65 mg/m² as a 1-hour IV infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m² two times a day continuously. |
|
| Overall Survival (OS) | The number of months measured from the date of randomization to the date of death due to any cause. | up to a maximum of 36 months |
| Diegem |
| Belgium |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | Frankfurt | Germany |
| Sanofi-Aventis Administrative Office | Budapest | Hungary |
| Sanofi-Aventis Administrative Office | Milan | Italy |
| Sanofi-Aventis Administrative Office | Porto Salvo | Portugal |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Barcelona | Spain |
| Sanofi-Aventis Administrative Office | Geneva | Switzerland |
| Sanofi-Aventis Administrative Office | Istanbul | Turkey (Türkiye) |
| Sanofi-Aventis Administrative Office | Guildford Surrey | United Kingdom |
| Death |
|
| Progressive disease |
|
| Withdrew consent |
|
| Withdrawal by Subject |
|
| Surgery |
|
| Patient did not receive study medication |
|
| Clinically progressive disease |
|
| Good prognosis |
|
| Investigator/Clinical decision |
|
| Discontinued at end of study |
|
Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle. |
| BG002 | (TEX) Taxotere, Eloxatin and Xeloda | Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Karnofsky Performance Status (KPS) | Number | participants |
|
| Weight loss during last 3 months | Number | participants |
|
| (TEF) Taxotere, Eloxatin and 5-fluorouracil |
Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle. |
| OG002 | (TEX) Taxotere, Eloxatin and Xeloda | Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle. |
|
|
| Secondary | Best Overall Response Rate (ORR) | Percentage of partial and complete responses, according to WHO criteria: Complete Response: Disappearance of all known disease, determined by 2 observations not less than 4 weeks apart. Partial Response: Decrease by at least 50% of the diameters of all measurable lesions, determined by 2 observations not less than 4 weeks apart. | 248 participants in the full analysis population (FAP). | Posted | Number | 95% Confidence Interval | percentage of participants | every 8 weeks up to a maximum of 36 months |
|
|
|
| Secondary | Overall Survival (OS) | The number of months measured from the date of randomization to the date of death due to any cause. | 248 participants in the full analysis population (FAP). | Posted | Median | 95% Confidence Interval | months | up to a maximum of 36 months |
|
|
|
| 35 |
| 78 |
| 75 |
| 78 |
| EG001 | (TEF) Taxotere, Eloxatin and 5-fluorouracil | Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle. | 24 | 88 | 87 | 88 |
| EG002 | (TEX) Taxotere, Eloxatin and Xeloda | Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle. | 36 | 82 | 77 | 82 |
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| ascites | Gastrointestinal disorders | Non-systematic Assessment |
|
| gastric perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
| intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| upper gastrointestinal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| colitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| enterocolitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| gastric hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| gastric ulcer perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
| gastrointestinal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| hematemesis | Gastrointestinal disorders | Non-systematic Assessment |
|
| ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
| inguinal hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| intestinal perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
| mechanical ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
| rectal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| volvulus | Gastrointestinal disorders | Non-systematic Assessment |
|
| febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| disseminated intravascular coagulation | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| general physical health deterioration | General disorders | Non-systematic Assessment |
|
| pyrexia | General disorders | Non-systematic Assessment |
|
| implant site reaction | General disorders | Non-systematic Assessment |
|
| mucosal inflammation | General disorders | Non-systematic Assessment |
|
| performance status decreased | General disorders | Non-systematic Assessment |
|
| asthenia | General disorders | Non-systematic Assessment |
|
| chest pain | General disorders | Non-systematic Assessment |
|
| device occlusion | General disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| generalised edema | General disorders | Non-systematic Assessment |
|
| device related infection | Infections and infestations | Non-systematic Assessment |
|
| gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| pneumonia | Infections and infestations | Non-systematic Assessment |
|
| abdominal wall abscess | Infections and infestations | Non-systematic Assessment |
|
| bronchopneumonia | Infections and infestations | Non-systematic Assessment |
|
| clostridium difficile colitis | Infections and infestations | Non-systematic Assessment |
|
| device related sepsis | Infections and infestations | Non-systematic Assessment |
|
| infection | Infections and infestations | Non-systematic Assessment |
|
| neutropenic sepsis | Infections and infestations | Non-systematic Assessment |
|
| pelvic abscess | Infections and infestations | Non-systematic Assessment |
|
| peritoneal abscess | Infections and infestations | Non-systematic Assessment |
|
| sepsis | Infections and infestations | Non-systematic Assessment |
|
| septic arthritis staphylococcal | Infections and infestations | Non-systematic Assessment |
|
| staphylococcal sepsis | Infections and infestations | Non-systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| acute pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| dysesthesia pharynx | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| respiratory arrest | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| cachexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hypovolemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| cardiac failure | Cardiac disorders | Non-systematic Assessment |
|
| cardiac failure congestive | Cardiac disorders | Non-systematic Assessment |
|
| cardiopulmonary failure | Cardiac disorders | Non-systematic Assessment |
|
| ataxia | Nervous system disorders | Non-systematic Assessment |
|
| facial paresis | Nervous system disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| peripheral motor neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| syncope | Nervous system disorders | Non-systematic Assessment |
|
| deep vein thromosis | Vascular disorders | Non-systematic Assessment |
|
| cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| cholecystitis acute | Hepatobiliary disorders | Non-systematic Assessment |
|
| hyperbilirubinemia | Hepatobiliary disorders | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| spondylolisthesis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| metastases to ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| renal failure acute | Renal and urinary disorders | Non-systematic Assessment |
|
| pyloric stenosis | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| investigations | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| hemoglobin decreased | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| stomatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| oral pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| asthenia | General disorders | Non-systematic Assessment |
|
| pyrexia | General disorders | Non-systematic Assessment |
|
| oedema peripheral | General disorders | Non-systematic Assessment |
|
| mucosal inflammation | General disorders | Non-systematic Assessment |
|
| oedema | General disorders | Non-systematic Assessment |
|
| peripheral sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| neuropathy peripheral | Nervous system disorders | Non-systematic Assessment |
|
| dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| paraesthesia | Nervous system disorders | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| dysaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| neurotoxicity | Nervous system disorders | Non-systematic Assessment |
|
| alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| nail disorder | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| skin reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hiccups | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| hypotension | Vascular disorders | Non-systematic Assessment |
|
| insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| weight decreased | Investigations | Non-systematic Assessment |
|
| neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
If no publication has occurred within 12 months after trial completion, the Investigator can publish the results. Prior to publication, the sponsor shall review the manuscript and can request changes, provided they do not jeopardize the accuracy and/or the scientific value of the publication. The approval is given in writing by the sponsor, not exceeding 90 days.
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |