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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
| Big Ten Cancer Research Consortium | OTHER |
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This is an open label, single-arm phase II, multi-institutional trial to evaluate the efficacy and safety of the combination of nab-paclitaxel and FOLFOX (FOLFOX-A) as first line therapy for patients diagnosed with histologically-confirmed advanced gastric/GEJ adenocarcinoma.
All patients will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m2 and leucovorin IV 400 mg/m2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m^2 and leucovorin IV 400 mg/m^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-paclitaxel 150 mg/m^2 | Drug | Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate will be calculated by combining the number of subjects who achieve complete response and partial response per RECIST 1.1 criteria.Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to <10 mm. | From C1D1 until death or up to a maximum of 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is defined by the date of the start of treatment to date of death from any cause. | From C1D1 until death or up to a maximum of 52 months |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Subject must meet all of the following applicable inclusion criteria to participate in this study:
Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
Histologically-confirmed advanced or metastatic unresectable gastric carcinoma, or adenocarcinoma of the gastroesophageal junction.
Prior neoadjuvant or adjuvant chemotherapy, hormonal therapy, immunotherapy, radiation or chemoradiotherapy must have been completed at least 6 months prior to documented recurrence or metastatic disease. NOTE: patients must not have received previous systemic treatment for metastatic disease.
Evaluable disease according to RECIST v1.1 for solid tumors, within 28 days prior to registration.
Demonstrate adequate organ function as described below; all screening labs to be obtained within 28 days prior to registration.
Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:
Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis), or agree to use and be able to comply with effective contraception without interruption 28 days prior to starting investigational product (IP), and while on study medication (including dose interruptions) and for 30 days following the last dose of IP; and
Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing prior to each treatment and after the end of study therapy. This applies even if the subject practices true abstinence* from heterosexual contact.
Male subjects must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy.
Exclusion Criteria
Subjects meeting any of the criteria below may not participate in the study:
Her-2 positive gastric tumor.
Treatment with any investigational products within 28 days prior to study registration.
Preexisting peripheral neuropathy is not allowed from any cause.
Known history of Human Immunodeficiency Virus (HIV) or Hepatitis C (baseline testing is not required).
Patients with active sepsis or pneumonitis
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to trial registration and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial registration.
Known hypersensitivity to fluorouracil (5-FU), oxaliplatin, or other platinum agents.
Known hypersensitivity to nab-paclitaxel or any of its excipients.
History of slowly progressive dyspnea and unproductive cough, or pulmonary conditions such as sarcoidosis, silicosis, idiopathic pulmonary fibrosis, hypersensitivity pneumonitis or multiple allergies. See section 6.5.1.
Has known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency (testing not required)
Ongoing or active infection requiring systemic treatment (must be afebrile for ≥ 48 hours prior to study registration)
Uncontrolled intercurrent illness including, but not limited to any of the following:
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
Known additional malignancy within the past 3 years. Exceptions include treated localized basal cell or squamous cell carcinoma of the skin, in situ cervical or vulvar carcinoma that has undergone potentially curative therapy, superficial bladder tumors (Ta, Tis & T1), ductal carcinoma in situ (DCIS) of the breast and low grade prostate cancer (Gleason sore 6). Any cancer curatively treated > 3 years prior to registration with no clinical evidence of recurrence is permitted.
Psychiatric illness/social situations that would limit compliance with study requirements.
Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
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| Name | Affiliation | Role |
|---|---|---|
| Al B. Benson, MD | Big Ten Cancer Research Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States | ||
| Univeristy of Illinois Cancer Center |
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| Label | URL |
|---|---|
| Big Ten Cancer Research Consortium Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nab-paclitaxel and FOLFOX-A | All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m^2 and leucovorin IV 400 mg/m^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Treatment |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2021 |
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Open-Label
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| Oxaliplatin 85 mg/m^2 | Drug | Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 |
|
|
| 5-FU 1200 mg/m^2 x 2 D | Drug | Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 |
|
|
| Leucovorin 400 mg/m^2 | Drug | Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 |
|
Progression free survival is defined as the time of treatment initiation until the criteria for disease progression per RECIST1.1 are met or until the date of a death event (any cause). Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).
| From C1D1 until death or up to a maximum of 36 months |
| Time to Progression (TTP) | Time to progression is defined as the time from registration date until the criteria for disease progression per RECIST1.1 are met. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions). | From C1D1 until PD or up to a maximum of 36 months |
| Number of Subjects Achieve Best Overall Response of CR, PR, SD and PD | Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to <10 mm. Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions). | From C1D1 until PD or up to a maximum of 36 months |
| Disease Control Rate (DCR) | The disease control rate is the proportion of all subjects with stable disease (SD) , or partial response (PR), or complete response (CR) according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to <10 mm. Stable disease is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | From C1D1 until PD or up to a maximum of 36 months |
| Safety and Toxicity Profile of the Combination of Nab-paclitaxel and FOLFOX | Safety and tolerability of abemaciclib in the combination of nab-paclitaxel and FOLFOX in patients with metastatic or advanced unresectable gastric, gastro-esophageal junction adenocarcinoma., assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4. | From C1D1 until death or up to a maximum of 52 months |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois | 60045 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Michigan State University | Lansing | Michigan | 48910 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Follow up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nab-paclitaxel and FOLFOX-A | All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m^2 and leucovorin IV 400 mg/m^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||||||||||||
| ECOG | Performance status Definition 0 Fully active; no performance restrictions.
| Count of Participants | Participants |
| ||||||||||||||||||||
| T Stage | TX: no information about the primary tumor, or it can't be measured;T (T3,T4) The higher the T number, the larger the tumor and/or the more it has grown into nearby tissues;NX: no information about the nearby lymph nodes, or they can't be assessed;N0:nearby lymph nodes do not contain cancer;N (N1, N2,N3) might describe the size, location, and/or the number of nearby lymph nodes affected by cancer. The higher the N number, the greater the cancer spread to nearby lymph nodes;M0:no distant cancer spread has been found;M1:cancer has been found to have spread to distant organs or tissues. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate | Objective response rate will be calculated by combining the number of subjects who achieve complete response and partial response per RECIST 1.1 criteria.Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to <10 mm. | 35 subjects out of 39 enrolled subjects were evaluable for objective response. | Posted | Count of Participants | Participants | From C1D1 until death or up to a maximum of 36 months |
|
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| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival is defined by the date of the start of treatment to date of death from any cause. | one subject out of 39 enrolled subject was a screen failure before start of therapy. | Posted | Median | 95% Confidence Interval | months | From C1D1 until death or up to a maximum of 52 months |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | Progression free survival is defined as the time of treatment initiation until the criteria for disease progression per RECIST1.1 are met or until the date of a death event (any cause). Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions). | one subject out of 39 enrolled subject was a screen failure before start of therapy. | Posted | Median | 95% Confidence Interval | months | From C1D1 until death or up to a maximum of 36 months |
| |||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | Time to progression is defined as the time from registration date until the criteria for disease progression per RECIST1.1 are met. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions). | one subject out of 39 enrolled subject was a screen failure before start of therapy. | Posted | Median | 95% Confidence Interval | months | From C1D1 until PD or up to a maximum of 36 months |
| |||||||||||||||||||||||||||
| Secondary | Number of Subjects Achieve Best Overall Response of CR, PR, SD and PD | Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to <10 mm. Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions). | one subject out of 39 enrolled subject was a screen failure before start of therapy. | Posted | Count of Participants | Participants | From C1D1 until PD or up to a maximum of 36 months |
| ||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | The disease control rate is the proportion of all subjects with stable disease (SD) , or partial response (PR), or complete response (CR) according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to <10 mm. Stable disease is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | 35 subjects out of 39 enrolled subjects were evaluable for response. | Posted | Number | percentage of participants | From C1D1 until PD or up to a maximum of 36 months |
| ||||||||||||||||||||||||||||
| Secondary | Safety and Toxicity Profile of the Combination of Nab-paclitaxel and FOLFOX | Safety and tolerability of abemaciclib in the combination of nab-paclitaxel and FOLFOX in patients with metastatic or advanced unresectable gastric, gastro-esophageal junction adenocarcinoma., assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4. | one subject out of 39 enrolled subject was a screen failure before start of therapy. | Posted | Count of Participants | Participants | From C1D1 until death or up to a maximum of 52 months |
|
Adverse events were assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every chemotherapy cycles thereafter, for up to 52 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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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 | Nab-paclitaxel and FOLFOX-A | All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m^2 and leucovorin IV 400 mg/m^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity. Nab-paclitaxel 150 mg/m^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 Oxaliplatin 85 mg/m^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 5-FU 1200 mg/m^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16 Leucovorin 400 mg/m^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15 | 29 | 38 | 22 | 38 | 38 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ANEMIA | Blood and lymphatic system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | CTCAEv4 | Non-systematic Assessment |
| |
| BRONCHIAL INFECTION | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| GASTRIC HEMORRHAGE | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| GASTROINTESTINAL DISORDERS - OTHER, SPECIFY | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| LOWER GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | CTCAEv4 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| OBSTRUCTION GASTRIC | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PAIN | General disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | CTCAEv4 | Non-systematic Assessment |
| |
| SEIZURE | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| SEPSIS | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
| |
| STROKE | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| UPPER GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | CTCAEv4 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | CTCAEv4 | Non-systematic Assessment |
| |
| AKATHISIA | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| ALKALINE PHOSPHATASE INCREASED | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| ALLERGIC REACTION | Immune system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| AMNESIA | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ANEMIA | Blood and lymphatic system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | CTCAEv4 | Non-systematic Assessment |
| |
| AORTIC VALVE DISEASE | Cardiac disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | CTCAEv4 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| BLOATING | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY | Blood and lymphatic system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| BLURRED VISION | Eye disorders | CTCAEv4 | Non-systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| BRUISING | Injury, poisoning and procedural complications | CTCAEv4 | Non-systematic Assessment |
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| BUTTOCK PAIN | Musculoskeletal and connective tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| CARDIAC DISORDERS - OTHER, SPECIFY | Cardiac disorders | CTCAEv4 | Non-systematic Assessment |
| |
| CATHETER RELATED INFECTION | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
| |
| CHEST PAIN - CARDIAC | Cardiac disorders | CTCAEv4 | Non-systematic Assessment |
| |
| CHILLS | General disorders | CTCAEv4 | Non-systematic Assessment |
| |
| CHOLESTEROL HIGH | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | CTCAEv4 | Non-systematic Assessment |
| |
| COGNITIVE DISTURBANCE | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| CONCENTRATION IMPAIRMENT | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| CONFUSION | Psychiatric disorders | CTCAEv4 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| CREATININE INCREASED | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DENTAL CARIES | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DYSARTHRIA | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DYSPHASIA | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY | Ear and labyrinth disorders | CTCAEv4 | Non-systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | CTCAEv4 | Non-systematic Assessment |
| |
| EDEMA LIMBS | General disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ENDOCARDITIS INFECTIVE | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ERYTHRODERMA | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| EXTRAPYRAMIDAL DISORDER | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| EYE DISORDERS - OTHER, SPECIFY | Eye disorders | CTCAEv4 | Non-systematic Assessment |
| |
| FACIAL PAIN | General disorders | CTCAEv4 | Non-systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | CTCAEv4 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | CTCAEv4 | Non-systematic Assessment |
| |
| FEVER | General disorders | CTCAEv4 | Non-systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| FLU LIKE SYMPTOMS | General disorders | CTCAEv4 | Non-systematic Assessment |
| |
| FLUSHING | Vascular disorders | CTCAEv4 | Non-systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| GASTROESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| GASTROINTESTINAL DISORDERS - OTHER, SPECIFY | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| GASTROINTESTINAL PAIN | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY | General disorders | CTCAEv4 | Non-systematic Assessment |
| |
| GENERALIZED MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| GINGIVAL PAIN | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| GLUCOSE INTOLERANCE | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HALLUCINATIONS | Psychiatric disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HEARING IMPAIRED | Ear and labyrinth disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HEMATURIA | Renal and urinary disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HEMORRHOIDS | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HEPATOBILIARY DISORDERS - OTHER, SPECIFY | Hepatobiliary disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HOARSENESS | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPERCALCEMIA | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPERKALEMIA | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPERMAGNESEMIA | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPERURICEMIA | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPOALBUMINEMIA | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPOCALCEMIA | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPOGLYCEMIA | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPOMAGNESEMIA | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPONATREMIA | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPOPHOSPHATEMIA | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | CTCAEv4 | Non-systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | CTCAEv4 | Non-systematic Assessment |
| |
| IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY | Immune system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
| |
| INFUSION RELATED REACTION | General disorders | CTCAEv4 | Non-systematic Assessment |
| |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY | Injury, poisoning and procedural complications | CTCAEv4 | Non-systematic Assessment |
| |
| INR INCREASED | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | CTCAEv4 | Non-systematic Assessment |
| |
| INVESTIGATIONS - OTHER, SPECIFY | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| IRON OVERLOAD | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| LOCALIZED EDEMA | General disorders | CTCAEv4 | Non-systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| MEMORY IMPAIRMENT | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| MUCOSAL INFECTION | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
| |
| MUCOSITIS ORAL | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| MUSCLE WEAKNESS LOWER LIMB | Musculoskeletal and connective tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY | Musculoskeletal and connective tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| NAIL DISCOLORATION | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| NAIL RIDGING | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEv4 | Non-systematic Assessment |
| |
| NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | CTCAEv4 | Non-systematic Assessment |
| |
| OBESITY | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ORAL DYSESTHESIA | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| ORAL PAIN | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PAIN | General disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PARESTHESIA | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PERICARDIAL TAMPONADE | Cardiac disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PERIORBITAL EDEMA | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PHOTOPHOBIA | Eye disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| POSTNASAL DRIP | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| PSYCHIATRIC DISORDERS - OTHER, SPECIFY | Psychiatric disorders | CTCAEv4 | Non-systematic Assessment |
| |
| RASH ACNEIFORM | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| RENAL AND URINARY DISORDERS - OTHER, SPECIFY | Renal and urinary disorders | CTCAEv4 | Non-systematic Assessment |
| |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | CTCAEv4 | Non-systematic Assessment |
| |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| SKIN HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
| |
| SLEEP APNEA | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| SORE THROAT | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| SPASTICITY | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| STOMACH PAIN | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | CTCAEv4 | Non-systematic Assessment |
| |
| THROMBOEMBOLIC EVENT | Vascular disorders | CTCAEv4 | Non-systematic Assessment |
| |
| TINNITUS | Ear and labyrinth disorders | CTCAEv4 | Non-systematic Assessment |
| |
| TUMOR LYSIS SYNDROME | Metabolism and nutrition disorders | CTCAEv4 | Non-systematic Assessment |
| |
| TUMOR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEv4 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY INFECTION | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
| |
| URINARY FREQUENCY | Renal and urinary disorders | CTCAEv4 | Non-systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | CTCAEv4 | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
| |
| URINARY TRACT PAIN | Renal and urinary disorders | CTCAEv4 | Non-systematic Assessment |
| |
| URINARY URGENCY | Renal and urinary disorders | CTCAEv4 | Non-systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | CTCAEv4 | Non-systematic Assessment |
| |
| VASCULAR DISORDERS - OTHER, SPECIFY | Vascular disorders | CTCAEv4 | Non-systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | CTCAEv4 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| WEIGHT GAIN | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| WEIGHT LOSS | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| WHEEZING | Respiratory, thoracic and mediastinal disorders | CTCAEv4 | Non-systematic Assessment |
| |
| WHITE BLOOD CELL DECREASED | Investigations | CTCAEv4 | Non-systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | CTCAEv4 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Data Analyst | Hoosier Cancer Research Network | 3179212050 | amajumdar@hoosiercancer.org |
| Oct 19, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
Not provided
Not provided
| study terminated |
|
| Primary Investigator Withdrawal |
|
| Switched to alternative therapy |
|
| Subject is now in Hospice |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Northwestern Memorial Hospital |
|
| Rutgers Cancer Institute of New Jersey |
|
| University of Illinois Hospital and Health Systems (Outpatient Cancer Center) |
|
| University of Iowa Hospitals and Clinics |
|
| University of Wisconsin Clinical Science Center |
|
|
| Title | Measurements |
|---|
|
| TX |
|
| Unknown T stage |
|
| N0 |
|
| N1 |
|
| N2 |
|
| N3 |
|
| NX |
|
| Unknown N stage |
|
| M0 |
|
| M1 |
|
| Unknown M stage |
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|