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| ID | Type | Description | Link |
|---|---|---|---|
| IUCRO-0088 |
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To study the efficacy of Alimta as a single agent in thymic cancers
The broad range of clinical activity of thymic carcinomas makes the likelihood of detecting efficacy of a single agent such as premetrexed a reasonable objective since these malignancies are relatively slow growing and exhibit a broad range of chemosensitivity to antineoplastic agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed | Experimental | Pemetrexed infusion once every 21 days (one cycle). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Premetrexed (Alimta) | Drug | Pemetrexed will be 500 mg/m2 IV every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (Complete and Partial Response) | The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Remission | Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis. | Time from the date of remission until progression or death, assessed up to 3 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Loehrer, M.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30121390 | Background | Gbolahan OB, Porter RF, Salter JT, Yiannoutsos C, Burns M, Chiorean EG, Loehrer PJ Sr. A Phase II Study of Pemetrexed in Patients with Recurrent Thymoma and Thymic Carcinoma. J Thorac Oncol. 2018 Dec;13(12):1940-1948. doi: 10.1016/j.jtho.2018.07.094. Epub 2018 Aug 16. |
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This protocol was based on getting 27 evaluable patients through a two-stage design
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| ID | Title | Description |
|---|---|---|
| FG000 | Thymoma | Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks |
| FG001 | Thymic Carcinoma | Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Thymoma | Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks |
| BG001 | Thymic Carcinoma | Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks |
| 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 | Objective Response Rate (Complete and Partial Response) | The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response. | All patients with at least one post baseline measurement. (26 evaluable - 15 T and 11 TC patients) | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 3 years |
|
Beginning of treatment until the end of the study, up to 3 years
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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 | Thymoma | Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SUPERIOR VENA CAVA SYNDROME (SVC) | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANC (NEUTROPENIA) | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick J. Loehrer, Sr., M.D. | IndianaU | (317)944-0920 | ploehrer@iu.edu |
Not provided
| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
Not provided
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| Grade 3/4 Treatment Related Adverse Events | To determine the toxicity of premetrexed in this patient population, the number of patients who experienced grade 3 or 4 adverse events will be reported that were treatment related (possibly, probably, definitely). | Up to 3 years |
| Withdrawal by Subject |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Thymic Carcinoma |
Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks |
|
|
| Secondary | Duration of Remission | Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis. | All patients with at least one post baseline measurement who had a response of CR or PR | Posted | Median | 95% Confidence Interval | months | Time from the date of remission until progression or death, assessed up to 3 years |
|
|
|
| Secondary | Grade 3/4 Treatment Related Adverse Events | To determine the toxicity of premetrexed in this patient population, the number of patients who experienced grade 3 or 4 adverse events will be reported that were treatment related (possibly, probably, definitely). | All patients enrolled and received treatment | Posted | Number | participants | Up to 3 years |
|
|
|
| 2 |
| 16 |
| 16 |
| 16 |
| EG001 | Thymic Carcinoma | Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks | 3 | 11 | 11 | 11 |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DYSPNEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FEVER | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BLOOD INFECTION (STAPHLOCOCCUS HOMINIS) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| ACHALASIA | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ANEMIA | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ANKLE EDEMA | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BILATERAL ANKLE EDEMA | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| EDEMA +1 | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| EDEMA - ANKLES | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| EDEMA-LEFT ARM | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SWOLLEN FACE/RED | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ARRHYTHIA (TACHYCARDIA) | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PERICARDIAL TAMPONADE | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DIABETES | Endocrine disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPOTHYROID | Endocrine disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPOTHYROIDISM | Endocrine disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BLURRY VISION | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DRY EYES | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| EYE DRAINAGE/ REDNESS | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| EYE SWELLING | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ANOREXIA (INTERMITTENT) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BLOATING | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CANDIDA ESOPHAGITIS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DIARRHEA (INTERMITTENT) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DYSPEPSIA (HEARTBURN)/REFLUX | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DYSPEPSIA (INTERMITTENT) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DYSPEPSIA (STOMACH ACHE) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DYSPNEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DYSPNEA (INTERMITTENT) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| GAS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| GERD | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEARTBURN | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INCONTINENCE | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTEMITTENT DYSPEPSIA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT CONSTIPATION | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT DIARRHEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT DYSPEPSIA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT NAUSEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT STOMACH PAIN | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT VOMITTING | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUCOSITIS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUCOSITIS (THRUSH) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUCOSITIS - ORAL CAVITY (MOUTH ULCERS) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUCOSITIS/STOMATITIS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NAUSEA (INTERMITTENT) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NAUSEA INTERMITTENT | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| TASTE ALTERATION | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FEVER | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INSOMNIA | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT ARTHRALGIA | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT CHEST PAIN | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT INSOMNIA | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT MIGRAINES | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT SORE THROAT | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| JOINT PAIN | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| LEFT SHOULDER PAIN | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| LIMBIC ENCEPHALITIS (CHARACTERIZED BY DROWSINESS, HALLUCINATIONS, LOSS OF SHORT TERM MEMORY, CONFUSI | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| LT SHOULDER PAIN | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUSCULOSKELATAL CHEST PAIN | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NIGHT SWEATS | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN (CHEST) | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - RIGHT CHEST INCISIONAL | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - RIGHT LUNG | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - RIGHT SHOULDER | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - RIGHT UPPER CHEST | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PANIC ATTACK INTERMITENT | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RIGHT HIP PAIN | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RIGHT SHOULDER AND BACK PAIN | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RIGHT-SIDED CHEST PAIN | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RUNNING NOSE | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RUNNY NOSE | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SHOULDER PAIN | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SINUS CONGESTION | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SINUS DRAINAGE | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SORE THROAT | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| STOMACH PAIN | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| FLUSHING (INTERMITTENT) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| FUNGAL INFECTION ON ANKLES | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| PHARGNGITIS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| SINUS INFECTIN | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| SINUS INFECTION | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| SINUSITIS (SINUS INFECTION) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| STAPH INFECTION | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| STREP INFLUENZA | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| ELEVATED AST | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| ELEVATED LFT'S | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| ELEVATED LIVER ENZYMES | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| ELEVATED LIVER FUNC. TEST | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| ELEVATED LIVER FUNCTION TEST | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPERBILIRUBINEMIA | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPERBILRUBEMIA | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPERGLYCEMIA | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPERLIPIDEMIA | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ANKLE/KNEE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ARTHRITIC PAIN | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BACK PAIN (INTERMITTENT FOR YEARS) | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BONE PAIN (LEGS) | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CHEST PAIN (MUSCULOSKELATAL) | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CHEST TIGHTNESS | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CYST ON LEFT BUTTOCK | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| GOUT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HIP PAIN | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - BACK MIDDLE | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - HANDS - INTERMITTAT BURNING SENSATION | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEADACHES | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEADACHES - INTERMITTENT | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT TINGLING IN FINGERS AND TOES | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| LEG WEAKNESS | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROPATHY | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROPATHY (FEET, TOES, & ELBOW NUMB) | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROPATHY (FINGERTIPS) | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROPATHY - FINGERS | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROPATHY - FINGERS AND TOES | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROPATHY - HANDS | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROPATHY - TOES | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROPATHY, SENSORY: TOES | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROPATHY-SENSORY- BALL OF FEET | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NUMBNESS - FEET | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NUMBNESS - LEFT CHEST INCISIONAL | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NUMBNESS OF BOTH LEGS | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RIGHT FOOT TREMOR | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RIGHT HAND TREMOR | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SENSORY NEUROPATHY - BOTTOM OF FEET NUMB | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ANXIETY (INTERMITTENT) | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| IRRITIABLE | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MOOD - DEPRESSION | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NOCTURIA | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - KIDNEY AREA LEFT AND RIGHT | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| POLYURIA | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ASTHMA (BRONCHIOSPASM) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ATCLECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HOARSENESS | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SLEEP APNEA | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| UPPER RESPIRATORY INFECTION | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ALOPECIA - THINNING | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DERMATITIS BILATERALLY | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HIVES | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPERPIGMENTATION OF PALMS OF HANDS | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PRURITIUS/ITCHING | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PRURITUS/ITCHING | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PRURITUS/ITCHING (INTERMITTENT) | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH (INFUSION SITE) | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH (INTERMITTENT) | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH (LEFT CHEST) | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH (NECK) INTERMITTENT | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH - NECK AND ABDOMEN AREA | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH - RED FACE AND ARMS | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SKIN - RED, RAISED RASH ON NECK AND UPPER CHEST | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SURGERY (REMOVAL SKIN CANCER) FACE & RIGHT ARM | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| UPPER CHEST ITCHING | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BLOOD CLOT-LEFT ARM | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INTERMITTENT BLOODY NOSE | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |