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This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and HER2 overexpression. The anticipated time on study treatment is 3-12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab, Myocet, Paclitaxel; Phase I | Experimental | Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 40 mg/ square meter (m^2), IV, every 3 weeks, from Week 1; if no dose limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles. Participants also received paclitaxel 60 mg/ m^2, IV, once per week, from Week 19; if no DLT was observed in ≥ 2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. |
|
| Trastuzumab, Myocet, Paclitaxel; Phase II | Experimental | Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 50 mg/m^2, IV, every 3 weeks, from Week 1 for 6 cycles. Participants also received paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Drug | Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment | For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks. | Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression - Percentage of Participants With an Event | Disease progression was defined as the time from the start of treatment to the date of the first recorded incident of disease progression, or the date of death due any cause. For measurable disease, disease progression was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of greater than (>)2 square centimeters (cm^2), or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madrid | 28027 | Spain |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab, Doxorubicin, Paclitaxel; Phase I | Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg per square meter (mg/m^2), IV, once every 3 weeks, from Week 1. If no dose-limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. |
| FG001 | Trastuzumab, Doxorubicin, Paclitaxel; Phase II | Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression. |
| FG002 | Trastuzumab Doxorubicin, Paclitaxel; Phase I and Phase II | During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab, Doxorubicin, Paclitaxel; Phase I | Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, from Week 1. If no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. |
| 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 | Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment | For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks. | All participants enrolled in Phase II of this study were included in the analysis. | Posted | Number | percentage of participants | Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
|
BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.
All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.
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 | Trastuzumab, Doxorubicin, Paclitaxel; Phase I & II | Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain NOS | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D017239 | Paclitaxel |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| paclitaxel | Drug | 60 mg/m^2 IV weekly; dose increased to 70 mg/m^2, and subsequently 80 mg/m^2, after 2 treatment cycles with no evidence of DLT until disease progression |
|
| Myocet | Drug | 40 mg/m^2 IV weekly; dose increased to 50 mg/m^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles |
|
| BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
| Time to Disease Progression | The median time, in months, from the start of treatment to disease progression event. | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
| Time to Treatment Response - Percentage of Participants With an Event | Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease. | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
| Time to Treatment Response | The median time, in months, from the start of treatment to treatment response event. | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
| Duration of Response - Percentage of Participants With an Event | Duration of response was defined as the time from date CR was first recorded to the date progressive disease (PD) was first noted. For measurable disease, PD was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of >2 cm^2, or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, PD was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions. | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
| Duration of Response | The median time, in months, from enrollment to duration of response event to Week 52. | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
| Time to Therapy Failure - Percentage of Participants With an Event | Therapy failure was defined as the date of the start of therapy to the date of withdrawal due to adverse events, progressive disease/insufficient therapeutic response, death, failure to return, or refusal of treatment/lack of cooperation/withdrawal of consent. Participants were censored at the last dose of treatment if no event was recorded. | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
| Time to Therapy Failure | The median time, in months, from treatment start to therapy failure event. Participants were censored at the last date of treatment if no event was recorded. | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
| Overall Survival (OS) - Percentage of Participants With an Event | OS was defined as the time from the date of the start of treatment to the date of death or the last date the participant was known to be alive. | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
| Overall Survival | The time, in months, from the start of treatment to OS event. The mean survival time and it's standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Administrative reasons |
|
| Death |
|
| Disease progression |
|
| BG001 | Trastuzumab, Doxorubicin, Paclitaxel; Phase II | Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression. |
| BG002 | Trastuzumab, Doxorubicin, Paclitaxel; Phase II and II | During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Trastuzumab, Doxorubicin, Paclitaxel; Phase II |
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression. |
|
|
| Secondary | Time to Disease Progression - Percentage of Participants With an Event | Disease progression was defined as the time from the start of treatment to the date of the first recorded incident of disease progression, or the date of death due any cause. For measurable disease, disease progression was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of greater than (>)2 square centimeters (cm^2), or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions. | All participants enrolled in Phase II of this study were included in the analysis. | Posted | Number | percentage of participants | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
|
|
|
| Secondary | Time to Disease Progression | The median time, in months, from the start of treatment to disease progression event. | All participants enrolled in Phase II of this study were included in the analysis. | Posted | Median | 95% Confidence Interval | months | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
|
|
|
| Secondary | Time to Treatment Response - Percentage of Participants With an Event | Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease. | All participants enrolled in Phase II of this study were included in the analysis. | Posted | Number | percentage participants | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
|
|
|
| Secondary | Time to Treatment Response | The median time, in months, from the start of treatment to treatment response event. | All participants enrolled in Phase II of this study were included in the analysis. | Posted | Median | 95% Confidence Interval | months | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
|
|
|
| Secondary | Duration of Response - Percentage of Participants With an Event | Duration of response was defined as the time from date CR was first recorded to the date progressive disease (PD) was first noted. For measurable disease, PD was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of >2 cm^2, or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, PD was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions. | Only participants with a response were included in the analysis. | Posted | Number | percentage of participants | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
|
|
|
| Secondary | Duration of Response | The median time, in months, from enrollment to duration of response event to Week 52. | All participants enrolled in Phase II of this study were included in the analysis. | Posted | Median | 95% Confidence Interval | months | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
|
|
|
| Secondary | Time to Therapy Failure - Percentage of Participants With an Event | Therapy failure was defined as the date of the start of therapy to the date of withdrawal due to adverse events, progressive disease/insufficient therapeutic response, death, failure to return, or refusal of treatment/lack of cooperation/withdrawal of consent. Participants were censored at the last dose of treatment if no event was recorded. | All participants enrolled in Phase II of this study were included in the analysis. | Posted | Number | percentage of participants | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
|
|
|
| Secondary | Time to Therapy Failure | The median time, in months, from treatment start to therapy failure event. Participants were censored at the last date of treatment if no event was recorded. | All participants enrolled in Phase II of this study were included in the analysis. | Posted | Median | 95% Confidence Interval | months | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
|
|
|
| Secondary | Overall Survival (OS) - Percentage of Participants With an Event | OS was defined as the time from the date of the start of treatment to the date of death or the last date the participant was known to be alive. | All participants enrolled in Phase II of this study were included in the analysis. | Posted | Number | percentage of participants | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
|
|
|
| Secondary | Overall Survival | The time, in months, from the start of treatment to OS event. The mean survival time and it's standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | All participants enrolled in Phase II of this study were included in the analysis. | Posted | Mean | Standard Error | months | BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years) |
|
|
|
| 26 |
| 69 |
| 63 |
| 69 |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI CTC 2.0 | Non-systematic Assessment |
|
| Intestinal obstruction NOS | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Cardiac failure NOS | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Endocarditis | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pancreatitis NOS | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Diarrhoea NOS | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Skin infection | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pancreatitis | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Respiratory tract infection NOS | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pneumonia NOS | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection NOS | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Thrombophlebitis | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Anaemia NOS | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Acute febrile neutrophilic dermatosis | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Ejection fraction decreased | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Mucosal inflammation NOS | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Amenorrhoea NOS | Reproductive system and breast disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Anaemia NOS | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Anxiety symptoms | Psychiatric disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Aphonia | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Body tinea | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Bowel sounds abnormal | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Breast abscess | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI CTC 2.0 | Non-systematic Assessment |
|
| Breast haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI CTC 2.0 | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Bronchitis NOS | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Bronchospasm NOS | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Cardiotoxicty | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Catarrh | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Catheter related infection | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Chest wall pain | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Congestion | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Cystitis-like symptom | Renal and urinary disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Death NOS | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Dermatitis NOS | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Dermatitis radiation NOS | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Diarrhoea NOS | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Ejection fraction decreased | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Face oedema | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Folliculitis | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Gastroenteritis NOS | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Haemoglobin abnormal | Investigations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Hand dermatitis | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | NCI CTC 2.0 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Hypersensitivity NOS | Immune system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Hypophonesis | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Hypotension NOS | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Influenza viral infections | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Injury asphyxiation | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Intermittent pyrexia | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Intertrigo candida | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | NCI CTC 2.0 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Laryngitis NOS | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Leukopenia NOS | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Limb discomfort NOS | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Lymphangitis | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Lymphoedema NOS | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI CTC 2.0 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Menometrorrhagia | Reproductive system and breast disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Milk allergy | Immune system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Mucosal inflammation NOS | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Muscle weakness NOS | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Mycosis fungoides | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI CTC 2.0 | Non-systematic Assessment |
|
| Mydriasis | Eye disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Nail discolouration | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Nail discomfort | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Nail disorder NOS | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Nail infection | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Nail toxicity | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Neuropathic pain | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Neuropathy NOS | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Neurotoxicity NOS | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Not coded | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Odynophagia | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Oedema NOS | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Oesophagitis NOS | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Onycholysis | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Oral infection | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Oropharyngeal candidiasis | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Otitis media NOS | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pain NOS | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Palmar erythema | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Paralysis | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Paratracheal lymphadenopathy | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Performance status decreased | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Peripheral neuropathy NOS | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Phlebitis NOS | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pigmentation disorder NOS | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Post procedural diarrhoea | Injury, poisoning and procedural complications | NCI CTC 2.0 | Non-systematic Assessment |
|
| Post procedural vomiting | Injury, poisoning and procedural complications | NCI CTC 2.0 | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pupils unequal | Eye disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Rash NOS | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Rectal tenesmus | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Rigors | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Scar pain | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Sinusitis NOS | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Skin reaction | Immune system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Skin toxicity | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Sweating increased | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Tachycardia NOS | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Transient ischaemic attack | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection NOS | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Urinary tract infection NOS | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
|
| Varicophlebitis | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Varicose veins NOS | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Vomiting NOS | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | NCI CTC 2.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D017437 |
| Skin and Connective Tissue Diseases |
| 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 |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |