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The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab and cisplatin was above a pre-specified threshold of 0.2 in the treatment of "triple negative" metastatic breast cancer.
The secondary objective of this study is to compare the differences between the two treatment groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival (OS), Time to Response (TTR) and Safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cisplatin and cetuximab | Experimental |
| |
| cisplatin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetuximab, cisplatin | Drug | Subjects will receive an initial dose of cetuximab 400 milligram per square meter (mg/m^2) followed by weekly doses of 250 mg/m^2. All doses will be given by intravenous (IV) infusion. Subjects will receive cisplatin (75 mg/m^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles. Administration of the Investigational Medicinal Product (IMP) will be stopped upon the first occurrence of disease progression, unacceptable toxicity or withdrawal of consent. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response (BOR) | Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). | Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Time | The PFS was defined as the duration from randomization until radiological progression according to investigator (based on RECIST) or death due to any cause. Only deaths within 85 days of last tumor assessment were considered. Participants without event were censored on the date of last tumor assessment. | Time from randomization to disease progression, death or last tumour assessment, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Baselga, Prof. | General Hospital, Boston, Massachusetts, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Campbelltown | New South Wales | Australia | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22248721 | Derived | Shamseddine AI, Farhat FS. Platinum-based compounds for the treatment of metastatic breast cancer. Chemotherapy. 2011;57(6):468-87. doi: 10.1159/000334093. Epub 2012 Jan 10. |
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Following a mandate of the Spanish health authority, data from all participants at site 0904 (Spain) were excluded from analyses due to evidence of misconduct, with significant deviations from Good Clinical Practice guidelines. Therefore, 173 of the 181 randomized participants were considered in the full analysis set (FAS).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cisplatin and Cetuximab | Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| cisplatin | Drug | Subjects will receive cisplatin (75 mg/m^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles. Subjects have the option of receiving cetuximab plus cisplatin at progression within the first 6 cycles, or cetuximab alone at progression after the 6 cycles. Administration of the IMP will be stopped upon the first occurrence of disease progression (except in cisplatin arm where switch to cetuximab plus cisplatin, or cetuximab alone is possible), unacceptable toxicity or withdrawal of consent. |
|
| Overall Survival (OS) Time | The OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier. | Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 20 June 2007, until cut-off date, 05 April 2010 |
| Time to Response (TTR) | The TTR was determined for participants whose confirmed BOR (based on RECIST) was either a CR or a PR . It was defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR. | Time from the first dose of study treatment (cetuximab or cisplatin) to first assessment of CR or PR, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009 |
| Safety- Number of Participants Experiencing Any Adverse Event (AE) | Number of participants experiencing any AE. AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. | Time from first dose up to 30 days after last dose of study treatment, reported between day of first dose of study treatment, 20 June 2007, until cut-off date 05 April 2010 |
| Liverpool |
| New South Wales |
| Australia |
| Research Site | Wollongong | New South Wales | Australia |
| Research Site | Malvern | Victoria | Australia |
| Research Site | Perth | Western Australia | Australia |
| Research Site | Bludesch-Gais | Austria |
| Research Site | Salzburg | Austria |
| Research Site | Vienna | Austria |
| Research Site | Brussels | Belgium |
| Research Site | Edegem | Belgium |
| Research Site | Ghent | Belgium |
| Research Site | Liège | Belgium |
| Research Site | Namur | Belgium |
| Research Site | Wilrijk | Belgium |
| Research Site | Cologne | Germany |
| Research Site | Frankfurt am Main | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Kiel | Germany |
| Research Site | München | Germany |
| Research Site | Rostock | Germany |
| Research Site | Dublin | Ireland |
| Research Site | Beersheba | Israel |
| Research Site | Haifa | Israel |
| Research Site | Jerusalem | Israel |
| Research Site | Kefar Sava | Israel |
| Research Site | Petah Tikva | Israel |
| Research Site | Rehovot | Israel |
| Research Site | Tel Aviv | Israel |
| Research Site | Tel Litwinsky | Israel |
| Research Site | Genova | Italy |
| Research Site | Modena | Italy |
| Research Site | Christchurch | New Zealand |
| Research Site | Wellington | New Zealand |
| Research Site | Coimbra | Portugal |
| Research Site | Lisbon | Portugal |
| Research Site | Porto | Portugal |
| Research Site | Barcelona | Spain |
| Research Site | Madrid | Spain |
| Research Site | Murcia | Spain |
| Research Site | Palma de Mallorca | Spain |
| Research Site | Valencia | Spain |
| Research Site | Zaragoza | Spain |
| Research Site | Cardiff | United Kingdom |
| Research Site | Guildford | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Manchester | United Kingdom |
| FG001 | Cisplatin | Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cisplatin and Cetuximab | Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity. |
| BG001 | Cisplatin | Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Naturally post menopausal participants | Number | participants |
| ||||||||||||||||
| Duration of breast cancer from primary tumor diagnosis to informed consent | Number of participants analyzed "N" are 110 and 56 for each arm group respectively for this specific parameter. | Median | Full Range | months |
| ||||||||||||||
| Participants categorized by site of metastasis | A participant can have more than one site of metastasis. | Number | participants |
| |||||||||||||||
| Duration of metastatic breast cancer from metastasis to informed consent | Number of participants analyzed "N" are 113 and 56 for each arm group respectively for this specific parameter. | Median | Full Range | months |
| ||||||||||||||
| Duration from initial breast cancer diagnosis to date of metastasis | Number of participants analyzed "N" are 108 and 55 for each arm group respectively for this specific parameter. | Median | Full Range | months |
|
| 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 | Best Overall Response (BOR) | Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). | FAS population included all participants who were randomized as described in the pre-assignment details. | Posted | Number | 95% Confidence Interval | percentage of participants | Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) Time | The PFS was defined as the duration from randomization until radiological progression according to investigator (based on RECIST) or death due to any cause. Only deaths within 85 days of last tumor assessment were considered. Participants without event were censored on the date of last tumor assessment. | FAS population included all participants who were randomized as described in the pre-assignment details. | Posted | Median | 95% Confidence Interval | months | Time from randomization to disease progression, death or last tumour assessment, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Time | The OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier. | FAS population included all participants who were randomized as described in the pre-assignment details. | Posted | Median | 95% Confidence Interval | months | Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 20 June 2007, until cut-off date, 05 April 2010 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | The TTR was determined for participants whose confirmed BOR (based on RECIST) was either a CR or a PR . It was defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR. | FAS population included all participants who were randomized as described in the pre-assignment details. | Posted | Median | 95% Confidence Interval | months | Time from the first dose of study treatment (cetuximab or cisplatin) to first assessment of CR or PR, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety- Number of Participants Experiencing Any Adverse Event (AE) | Number of participants experiencing any AE. AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. | Safety population included all the participants who received at least 1 dose of study medication (that is cisplatin or cetuximab). | Posted | Number | participants | Time from first dose up to 30 days after last dose of study treatment, reported between day of first dose of study treatment, 20 June 2007, until cut-off date 05 April 2010 |
|
Time from first dose up to 30 days after last dose of study treatment, reported between day of first dose of study treatment, 20 June 2007, until cut-off date 05 April 2010
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP, regardless of causal relationship.
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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 | Cisplatin and Cetuximab | Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. | 41 | 114 | 112 | 114 | ||
| EG001 | Cisplatin | Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of progressive disease (PD), unacceptable toxicity or withdrawal of consent. | 13 | 57 | 55 | 57 | ||
| EG002 | Cisplatin Alone Switched to Cetuximab | On progression, participants in the cisplatin group had the option to switch to cisplatin (75 mg/m^2 IV infusion) plus cetuximab (initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion) if the progressive disease was reported during the 6 cisplatin cycles or to cetuximab alone (initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion) if the progression was reported after the 6 cisplatin cycles. | 6 | 31 | 28 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Abdominal Distention | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Abdomial Pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Catheter Site Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Post Procedural Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Soft Tissue Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Streptococcal Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Oxygen Saturation Decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Metastases to Central Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Coma Hepatic | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dyspnoae | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Arterial Thrombosis Limb | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
| |
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Ototoxicity | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Nail Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Breast Pain | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
Participants were randomized to 2 groups in a 2:1 ratio.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| >= 65 years |
|
| Male |
|
| No |
|
| Lymph nodes (by medical review) |
|
| Bone |
|
| Liver |
|
| Skin |
|
| Other |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|