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The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E7080 (Dose Escalation Cohort) | Experimental | This will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin. |
|
| E7080 (Expansion Cohort) | Experimental | Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7080 | Drug | Drug: E7080 will be administered orally starting at a dose of 6 mg twice daily during the 7-day run-in period and for 3 weeks (Cycle 1). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants. | 7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel. | At Screening, on Day 22 of every even cycle, and at discontinuation | |
| Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel. | At various time points until Day 22 of Cycle 1 |
Not provided
Inclusion criteria:
Exclusion criteria:
Subjects who have ever received the following therapy for non-small cell lung cancer (NSCLC):
Subjects with the severe complications or disease history.
Subjects with brain metastasis accompanying clinical symptoms or requiring treatment.
Subjects with simultaneous or metachronous cancers.
Subjects who cannot take oral medication.
Subjects who are using drugs that strongly inhibit or induce cytochrome P450 (CYP) 3A4.
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| Name | Affiliation | Role |
|---|---|---|
| Wataru Yusa | Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunto-gun | Shizuoka | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23860537 | Derived | Nishio M, Horai T, Horiike A, Nokihara H, Yamamoto N, Takahashi T, Murakami H, Yamamoto N, Koizumi F, Nishio K, Yusa W, Koyama N, Tamura T. Phase 1 study of lenvatinib combined with carboplatin and paclitaxel in patients with non-small-cell lung cancer. Br J Cancer. 2013 Aug 6;109(3):538-44. doi: 10.1038/bjc.2013.374. Epub 2013 Jul 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | E7080 4 mg BID (Dose Escalation) | E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks. |
| FG001 | E7080 6 mg BID (Dose Escalation) | E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks. |
| FG002 | E7080 4 mg BID (Expansion) | Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | E7080 4 mg BID (Dose Escalation) | E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (Area under the curve (AUC) 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel. | Not Posted | At Screening, on Day 22 of every even cycle, and at discontinuation | |||||||||||||
| Primary | Maximum Tolerated Dose (MTD) | Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants. | DLTs were analyzed on the Safety Analysis Set; however subjects with 75% or less treatment compliance for E7080 in Cycle 1 or those who discontinued the study and had no confirmed data on tolerability up to Cycle 1 Day 22 were excluded from this analysis. | Posted | Number |
Throughout the study until 30 days after last dose
All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E7080 4 mg BID (Dose Escalation) | E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wataru Yusa | Eisai Co., Ltd. | +81 3-3817-5252 | 5252 |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C531958 | lenvatinib |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
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| E7080 | Drug | Maximum tolerated dose determined in the Dose-Escalation Cohort will be administered to the Expansion Cohort. After E7080 is taken on Day 1, paclitaxel (200 mg/m2) will be administered intravenously (IV), followed by IV carboplatin (AUC 6.0 min/mg/mL). |
|
| Paclitaxel | Drug | Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080. |
|
| Carboplatin | Drug | Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel. |
|
| To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel. | Refer safety section for safety analysis | Throughout the study until 30 days after last dose |
| Chuo-ku |
| Tokyo |
| Japan |
| Koto-ku | Tokyo | Japan |
| BG001 |
| E7080 6 mg BID (Dose Escalation) |
E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks. |
| BG002 | E7080 4 mg BID (Expansion) | Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| mg BID |
| 7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1 |
|
|
|
| Secondary | Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel. | Not Posted | At various time points until Day 22 of Cycle 1 |
| Secondary | To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel. | Refer safety section for safety analysis | Not Posted | Throughout the study until 30 days after last dose |
| 3 |
| 6 |
| 6 |
| 6 |
| EG001 | E7080 6 mg BID (Dose Escalation) | E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks. | 2 | 6 | 6 | 6 |
| EG002 | E7080 4 mg BID (Expansion) | Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks. | 6 | 16 | 16 | 16 |
| Wound | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v14.0 | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Metastatses to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v14.0 | Non-systematic Assessment |
|
| Erythropenia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Ear pruritus | Ear and labyrinth disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Thyroiditis subacute | Endocrine disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Anal erosion | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Gingival discolouration | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Extravasation | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Gingival infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Occult blood | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA v14.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v14.0 | Non-systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v14.0 | Non-systematic Assessment |
|
| Cranial nerve disorder | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Urethral haemorrhage | Renal and urinary disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Penile haemorrhage | Reproductive system and breast disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Angiopathy | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA v14.0 | Non-systematic Assessment |
|
Not provided
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |