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| Name | Class |
|---|---|
| InterMune | INDUSTRY |
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The purpose of this study is to evalute the response and toxicity of metastatic colorectal cancer patients to the regimen of gamma interferon added to bolus and infusional 5-fluorouracil and leucovorin (GFL) with or without bevacizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratum 1 | Experimental | Patients in stratum 1 have not received prior chemotherapy in the metastatic setting. |
|
| Stratum 2 | Experimental | Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Fluorouracil | Drug | 5-FU bolus was administered at 400mg/m^2 on day 1 and day 2 of each cycle. 5-FU at 600 mg/m^2 infusion was administered over 22 hours on day 1 and day 2 of each cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Response (BR) | BR is recorded from start of treatment until progressive disease (PD). Imaging was repeated by same technique after every 4 cycles of treatment. Response was evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0 and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; PD, increase in existing lesions or new lesions. | After every 4 cycles of treatment (approximately every 56 days for up to about 280 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Early Response Rate (RR) (Stratum 1 Only) | Early RR evaluated in stratum 1 to see if bevacizumab (bev) would be added to GFL treatment (tx). Patients with stable disease (SD) pre 5th cycle of tx had bev added. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Per RECIST and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; SD, neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD), increase in existing lesions or new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Schwartzberg, MD | Vector Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The West Clinic | Memphis | Tennessee | 38120 | United States |
Informed consent was obtained from all subjects. All subjects underwent a screening period during which pre-study assessments were completed. Subjects were assigned to a stratum, based on whether or not they had received previous treatment in the metastatic setting, at the time of study enrollment.
One community oncology research site in the US within the ACORN Network participated in this study. Phase II enrollment started in February 2006 and was closed in December 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stratum 1 | Patients in stratum 1 have not received prior chemotherapy in the metastatic setting. |
| FG001 | Stratum 2 | Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stratum 1 | Patients in stratum 1 have not received prior chemotherapy in the metastatic setting. |
| BG001 | Stratum 2 | Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Best Response (BR) | BR is recorded from start of treatment until progressive disease (PD). Imaging was repeated by same technique after every 4 cycles of treatment. Response was evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0 and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; PD, increase in existing lesions or new lesions. | The best response is the best response recorded from the start of treatment until disease progression. Imaging was repeated by same technique after every 4 cycles of treatment. Subjects in both strata were evaluated for this outcome. | Posted | Number | Participants | After every 4 cycles of treatment (approximately every 56 days for up to about 280 days) |
|
Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days).
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
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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 | Stratum 1 | Patients in stratum 1 have not received prior chemotherapy in the metastatic setting. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
Enrollment to stratum 1 was closed early due to difficulty accruing the required number of patients in this stratum.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Scientific Affairs | Accelerated Community Oncology Research Network, Inc. | 901-435-5570 | mwalker@acorncro.com |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D007371 | Interferon-gamma |
| C554125 | interferon gamma-1b |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Leucovorin (LV) | Drug | Leucovorin 200mg/m^2 was administered over 2 hours on day 1 and day 2 of each cycle. |
|
|
| Gamma-Interferon-1b (IFN-γ) | Drug | Gamma-Interferon 150 mcg/m^2 was administered by subcutaneous injection on day 1 of each cycle immediately before treatment with 5-FU and LV, and on day 3 of each cycle immediately after treatment with 5-FU and LV. |
|
|
| Bevacizumab | Drug | Bevacizumab 5mg/kg was only added to the treatment regimen of patients in stratum 1 who demonstrated stable disease on imaging repeated prior to the 5th cycle of treatment. Bavacizumab was administered on day 4 of each cycle. |
|
|
| After 4 cycles of treatment (approximately 56 days) |
| Time to Progression | Patients were censored if they did not progress, stopped particiaption due to an adverse event, or withdrew consent following the start of study treatment. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0, Progressive Disease (PD) is defined as a measurable increase in smallest diameter of any target or non-target lesion, or the appearance of new lesions, since baseline. | From date of study treatment start until date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients in stratum 1 have not received prior chemotherapy in the metastatic setting. |
| OG001 | Stratum 2 | Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting. |
|
|
| Secondary | Early Response Rate (RR) (Stratum 1 Only) | Early RR evaluated in stratum 1 to see if bevacizumab (bev) would be added to GFL treatment (tx). Patients with stable disease (SD) pre 5th cycle of tx had bev added. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Per RECIST and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; SD, neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD), increase in existing lesions or new lesions. | Prior to the 5th cycle of treatment, early response rate was evaluated in patients in stratum 1 to assess whether bevacizumab would be added to the GFL treatment regimen. Stratum 1 patients with SD at this time point will have bevacizumab added to the regimen. Subjects in stratum 2 were not evaluated for this outcome. | Posted | Number | Participants | After 4 cycles of treatment (approximately 56 days) |
|
|
|
| Secondary | Time to Progression | Patients were censored if they did not progress, stopped particiaption due to an adverse event, or withdrew consent following the start of study treatment. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0, Progressive Disease (PD) is defined as a measurable increase in smallest diameter of any target or non-target lesion, or the appearance of new lesions, since baseline. | Posted | Median | 95% Confidence Interval | Months | From date of study treatment start until date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months |
|
|
|
| 2 |
| 20 |
| 19 |
| 20 |
| EG001 | Stratum 2 | Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting. | 5 | 27 | 26 | 27 |
| Cardiac arrest | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Asthenia | General disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Suprapubic pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Abdominal infection | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | CTCAE (2.0) | Non-systematic Assessment |
|
| Urine output decreased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
|
| Weight decreased | Investigations | CTCAE (2.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | CTCAE (2.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Asthenia | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Chest pain | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Face oedema | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Malaise | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Oedema | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pyrexia | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Blood pressure decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Body temperature | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Heart rate irregular | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| International normalised ratio increased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Prothrombin time prolonged | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Weight decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fluid intake reduced | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Mental impairment | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Scrotal irritation | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
If the Investigator wishes to make a submission for a presentation or publication, the Investigator shall submit all such materials to InterMune at least 60 days prior to the date on which such submission is proposed to be made, and InterMune shall provide timely review of such materials. InterMune may cause the presentation or submission to be delayed for up to 60 additional days if patentable material or proprietary information is identified.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| 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 |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D016215 | Macrophage-Activating Factors |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Progressive disease (PD) |
|
| Not evaluable (NE) |
|