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| ID | Type | Description | Link |
|---|---|---|---|
| B9E-JE-MB22 | Other Identifier | Eli Lilly and Company |
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To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine | Drug | Phase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation) Phase 2: dose determined by phase 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Responders are patients with complete response or partial response. | baseline to measured progressive disease |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | time of response to progressive disease |
| Time to Progressive Disease |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aichi | 464-8681 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1 | Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles |
| FG001 | Dose Level 2 | Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1 | Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles |
| BG001 | Dose Level 2 | Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles |
| 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 | Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Responders are patients with complete response or partial response. | Posted | Number | participants | baseline to measured progressive disease |
|
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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 | Dose Level 1 | Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemoglobin decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
Not provided
Not provided
Not provided
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| paclitaxel | Drug | Phase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles |
|
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. |
| baseline to measured progressive disease |
| Number of Participants Alive at One Year (1-Year Survival) | baseline to date of death from any cause, evaluated at 1 year |
| Pharmacokinetics - Maximum Plasma Concentration (Cmax) | Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1. | cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) |
| Pharmacokinetics - Area Under the Concentration Curve (AUC) | Area under the concentration curve from time zero to infinity. | cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) |
| Pharmacokinetics - Half Life (t½) | Apparent elimination half-life. | cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) |
| Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chiba | 296-8602 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ehime | 790-0007 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fukuoka | 814-0180 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gunma | 373-8550 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hiroshima | 737-0023 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hokkaido | 060-0006 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kagoshima | 892-0833 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kanagawa | 259-1193 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kumamoto | 862-8505 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Numakunai | 020-8505 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Osaka | 590-0064 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saitama | 338-8553 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shizuoka | 430-8558 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokyo | 104-8560 | Japan |
| Lack of Efficacy |
|
| Patient Condition Aggrevated |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| Criteria for Starting Next Cycle Not Met |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Age at Primary Diagnosis | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
|
| Body Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | centimeters |
|
|
|
|
| Secondary | Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | Posted | Median | Full Range | months | time of response to progressive disease |
|
|
|
| Secondary | Time to Progressive Disease | Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. | Posted | Median | Full Range | days | baseline to measured progressive disease |
|
|
|
| Secondary | Number of Participants Alive at One Year (1-Year Survival) | Posted | Number | participants | baseline to date of death from any cause, evaluated at 1 year |
|
|
|
| Secondary | Pharmacokinetics - Maximum Plasma Concentration (Cmax) | Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1. | Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables. | Posted | Geometric Mean | Full Range | nanograms per milliliter (ng/mL) | cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) |
|
|
|
| Secondary | Pharmacokinetics - Area Under the Concentration Curve (AUC) | Area under the concentration curve from time zero to infinity. | Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables. | Posted | Geometric Mean | Full Range | nanograms*hour per milliliter (ng*hr/mL) | cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) |
|
|
|
| Secondary | Pharmacokinetics - Half Life (t½) | Apparent elimination half-life. | Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables. | Posted | Geometric Mean | Full Range | hours | cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes) |
|
|
|
| 1 |
| 6 |
| EG001 | Dose Level 2 | Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles | 3 | 56 |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Panic disorder | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Angiopathy | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Localised oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alanine amiontransferase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood calcium increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Leucine aminopeptidase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Cautery to nose | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Lentigo | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vocal cord paralysis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Olfactory nerve disorder | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Residual urine | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cystitis-like symptom | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Breast discharge | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Feeling drunk | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hangover | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood urea decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood chloride decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Creatine phosphokinase decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Alanine aminotransferase decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Aspartate aminotransferase decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood cholinesterase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood creatinine decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood sodium increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Haematocrit increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| High density lipoprotein increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Lymphocyte count increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Urobilin urine present | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Central venous catheterisation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Catheterisation venous | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |