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1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Pericardial effusion 1/115 (0.87%) secondary trial: Febrile Neutropenia 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Pericardial effusion 1/115 (0.87%) secondary trial: Retinopathy Hypertensive 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Pericardial effusion 1/115 (0.87%) secondary trial: Febrile Infection 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Pericardial effusion 1/115 (0.87%) secondary trial: Postoperative Wound Complication 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Pericardial effusion 1/115 (0.87%) secondary trial: Cardiac Imaging Procedure Abnormal 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Pericardial effusion 1/115 (0.87%) secondary trial: Malignant Melanoma In Situ 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Pericardial effusion 1/115 (0.87%) secondary trial: Suicide Attempt 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Pericardial effusion 1/115 (0.87%) secondary trial: Dyspnoea 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Abdominal pain 0/115 (0.00%) secondary trial: Total: 8/54 (14.81%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Abdominal pain 0/115 (0.00%) secondary trial: Anaemia 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Abdominal pain 0/115 (0.00%) secondary trial: Febrile Neutropenia 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Abdominal pain 0/115 (0.00%) secondary trial: Retinopathy Hypertensive 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Abdominal pain 0/115 (0.00%) secondary trial: Febrile Infection 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Abdominal pain 0/115 (0.00%) secondary trial: Postoperative Wound Complication 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Abdominal pain 0/115 (0.00%) secondary trial: Cardiac Imaging Procedure Abnormal 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Abdominal pain 0/115 (0.00%) secondary trial: Malignant Melanoma In Situ 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Abdominal pain 0/115 (0.00%) secondary trial: Suicide Attempt 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Abdominal pain 0/115 (0.00%) secondary trial: Dyspnoea 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Ascites 0/115 (0.00%) secondary trial: Total: 8/54 (14.81%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Ascites 0/115 (0.00%) secondary trial: Anaemia 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Ascites 0/115 (0.00%) secondary trial: Febrile Neutropenia 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Ascites 0/115 (0.00%) secondary trial: Retinopathy Hypertensive 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Ascites 0/115 (0.00%) secondary trial: Febrile Infection 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Ascites 0/115 (0.00%) secondary trial: Postoperative Wound Complication 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Ascites 0/115 (0.00%) secondary trial: Cardiac Imaging Procedure Abnormal 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Ascites 0/115 (0.00%) secondary trial: Malignant Melanoma In Situ 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Ascites 0/115 (0.00%) secondary trial: Suicide Attempt 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Ascites 0/115 (0.00%) secondary trial: Dyspnoea 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Diarrhoea 4/115 (3.48%) secondary trial: Total: 8/54 (14.81%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Diarrhoea 4/115 (3.48%) secondary trial: Anaemia 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Diarrhoea 4/115 (3.48%) secondary trial: Febrile Neutropenia 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Diarrhoea 4/115 (3.48%) secondary trial: Retinopathy Hypertensive 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Diarrhoea 4/115 (3.48%) secondary trial: Febrile Infection 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Diarrhoea 4/115 (3.48%) secondary trial: Postoperative Wound Complication 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Diarrhoea 4/115 (3.48%) secondary trial: Cardiac Imaging Procedure Abnormal 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Diarrhoea 4/115 (3.48%) secondary trial: Malignant Melanoma In Situ 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Diarrhoea 4/115 (3.48%) secondary trial: Suicide Attempt 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Diarrhoea 4/115 (3.48%) secondary trial: Dyspnoea 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Gingival bleeding 0/115 (0.00%) secondary trial: Total: 8/54 (14.81%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Gingival bleeding 0/115 (0.00%) secondary trial: Anaemia 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Gingival bleeding 0/115 (0.00%) secondary trial: Febrile Neutropenia 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Gingival bleeding 0/115 (0.00%) secondary trial: Retinopathy Hypertensive 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Gingival bleeding 0/115 (0.00%) secondary trial: Febrile Infection 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Gingival bleeding 0/115 (0.00%) secondary trial: Postoperative Wound Complication 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Gingival bleeding 0/115 (0.00%) secondary trial: Cardiac Imaging Procedure Abnormal 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Gingival bleeding 0/115 (0.00%) secondary trial: Malignant Melanoma In Situ 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Gingival bleeding 0/115 (0.00%) secondary trial: Suicide Attempt 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Gingival bleeding 0/115 (0.00%) secondary trial: Dyspnoea 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Intestinal haemorrhage 0/115 (0.00%) secondary trial: Total: 8/54 (14.81%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Intestinal haemorrhage 0/115 (0.00%) secondary trial: Anaemia 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Intestinal haemorrhage 0/115 (0.00%) secondary trial: Febrile Neutropenia 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Intestinal haemorrhage 0/115 (0.00%) secondary trial: Retinopathy Hypertensive 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Intestinal haemorrhage 0/115 (0.00%) secondary trial: Febrile Infection 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Intestinal haemorrhage 0/115 (0.00%) secondary trial: Postoperative Wound Complication 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Intestinal haemorrhage 0/115 (0.00%) secondary trial: Cardiac Imaging Procedure Abnormal 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Intestinal haemorrhage 0/115 (0.00%) secondary trial: Malignant Melanoma In Situ 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Intestinal haemorrhage 0/115 (0.00%) secondary trial: Suicide Attempt 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Intestinal haemorrhage 0/115 (0.00%) secondary trial: Dyspnoea 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Nausea 3/115 (2.61%) secondary trial: Total: 8/54 (14.81%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Nausea 3/115 (2.61%) secondary trial: Anaemia 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Nausea 3/115 (2.61%) secondary trial: Febrile Neutropenia 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Nausea 3/115 (2.61%) secondary trial: Retinopathy Hypertensive 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Nausea 3/115 (2.61%) secondary trial: Febrile Infection 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Nausea 3/115 (2.61%) secondary trial: Postoperative Wound Complication 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Nausea 3/115 (2.61%) secondary trial: Cardiac Imaging Procedure Abnormal 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Nausea 3/115 (2.61%) secondary trial: Malignant Melanoma In Situ 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Nausea 3/115 (2.61%) secondary trial: Suicide Attempt 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af | primary trial: Nausea 3/115 (2.61%) secondary trial: Dyspnoea 1/54 (1.85%) There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | 1 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Lapatinib With Paclitaxel secondary trial: AlloDerm RTU the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Lapatinib With Paclitaxel secondary trial: Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement. the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Lapatinib With Paclitaxel secondary trial: AlloDerm RTU the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Lapatinib With Paclitaxel secondary trial: SurgiMend PRS the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Lapatinib With Paclitaxel secondary trial: Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement. the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Lapatinib With Paclitaxel secondary trial: SurgiMend PRS the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. secondary trial: AlloDerm RTU the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. secondary trial: Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement. the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. secondary trial: AlloDerm RTU the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. secondary trial: SurgiMend PRS the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. secondary trial: Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement. the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. secondary trial: SurgiMend PRS the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Placebo With Paclitaxel secondary trial: AlloDerm RTU the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Placebo With Paclitaxel secondary trial: Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement. the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Placebo With Paclitaxel secondary trial: AlloDerm RTU the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Placebo With Paclitaxel secondary trial: SurgiMend PRS the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Placebo With Paclitaxel secondary trial: Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement. the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Placebo With Paclitaxel secondary trial: SurgiMend PRS the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. secondary trial: AlloDerm RTU the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. secondary trial: Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement. the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. secondary trial: AlloDerm RTU the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. secondary trial: SurgiMend PRS the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. secondary trial: Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement. the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
57f3a264-9119-4931-9f9c-9cb20e945973 | primary trial: Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. secondary trial: SurgiMend PRS the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | 0 |
589e2f5b-9286-465b-8162-bb1549cd5ece | Objective Response Rate (ORR) At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |
589e2f5b-9286-465b-8162-bb1549cd5ece | An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response. At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |
589e2f5b-9286-465b-8162-bb1549cd5ece | Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |
589e2f5b-9286-465b-8162-bb1549cd5ece | Time frame: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008) At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |
589e2f5b-9286-465b-8162-bb1549cd5ece | Arm/Group Title: Fulvestrant 250 mg At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |
589e2f5b-9286-465b-8162-bb1549cd5ece | Arm/Group Description: Fulvestrant 250 mg At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |
589e2f5b-9286-465b-8162-bb1549cd5ece | Overall Number of Participants Analyzed: 45 At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |
589e2f5b-9286-465b-8162-bb1549cd5ece | Measure Type: Number At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | 1 |