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| ID | Type | Description | Link |
|---|---|---|---|
| I3F-MC-JSRB | Other Identifier | Eli Lilly and Company |
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The objective of this phase 1 study is to evaluate the safety and tolerability of Notch Inhibitor in participants with advanced cancer. This study includes dose escalation and dose confirmation components.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900009 | Experimental | Dose escalation phase: 2 milligrams (mg), 4 mg, 8 mg, 15 mg, 30 mg, 45 mg and 60mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle. Dose confirmation phase: 30 mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle. Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900009 - Dose Escalation Phase (Part A) | Drug | 2 milligrams (mg), 4 mg, 8 mg, 15 mg, 30 mg, 45 mg and 60mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle. Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Effects | Clinically significant effects are study drug related serious adverse events (SAEs) and study drug related treatment emergent adverse events (TEAEs). A summary of all SAEs and all other non-SAEs regardless of causality is located in the Reported Adverse Events module. | Baseline to study completion up to 18.7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Dose Range for Phase 2 Studies | Recommended Phase 2 dose was determined by the maximum tolerated dose (MTD). MTD is the highest dose with <33% of participants having a dose-limiting toxicity (DLT) during Cycle 1. DLT is an adverse event (AE) occurring for a participant enrolled in Part A that is likely related to the study drug and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 4.02) Grade 3 or 4 nonhematologic toxicity except for Grade 3 nausea, vomiting or electrolyte disturbance; Grade 3 nausea, vomiting or electrolyte disturbance that persists more than 2 days despite maximal supportive intervention; Grade 4 hematological toxicity that persists more than 5 days; Grade 3 or 4 thrombocytopenia with bleeding; Grade 3 or 4 neutropenia with fever. A DLT can be declared if a participant experiences increasing toxicity during treatment. |
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Inclusion Criteria:
The participants must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have ceased to provide clinical benefit for their disease.
The participants must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced and/or metastatic.
Have adequate organ function including:
Have a performance status less than or equal to 1 for Dose Escalation and less than or equal to 2 for Dose Confirmation on the Eastern Cooperative Oncology Group (ECOG) scale.
Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment-related toxicity resolved to baseline) except for residual alopecia.
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug.
Females with childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of study drug.
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. | Oklahoma City | Oklahoma | 73104 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26798966 | Derived | Pant S, Jones SF, Kurkjian CD, Infante JR, Moore KN, Burris HA, McMeekin DS, Benhadji KA, Patel BKR, Frenzel MJ, Kursar JD, Zamek-Gliszczynski MJ, Yuen ESM, Chan EM, Bendell JC. A first-in-human phase I study of the oral Notch inhibitor, LY900009, in patients with advanced cancer. Eur J Cancer. 2016 Mar;56:1-9. doi: 10.1016/j.ejca.2015.11.021. Epub 2016 Jan 19. |
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Any participant who completed Cycle 1 or discontinued due to an adverse event (AE) in Part A is considered a completer. Any participant who completed cycle 1 or discontinued due to an AE or progressive disease in Part B was considered a completer.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2 mg LY900009 - Dose Escalation Phase (Part A) | 2 milligram (mg) LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| FG001 | 4 mg LY900009 - Dose Escalation Phase (Part A) | 4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| FG002 | 8 mg LY900009 - Dose Escalation Phase (Part A) | 8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| FG003 | 15 mg LY900009 - Dose Escalation Phase (Part A) | 15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| FG004 | 30 mg LY900009 - Dose Escalation Phase (Part A) | 30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| FG005 | 45 mg LY900009 - Dose Escalation Phase (Part A) | 45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| FG006 | 60 mg LY900009 - Dose Escalation Phase (Part A) | 60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| FG007 | 30 mg LY900009 - Dose Confirmation Phase (Part B) | 30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2 mg LY900009 - Dose Escalation Phase (Part A) | 2 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| BG001 | 4 mg LY900009 - Dose Escalation Phase (Part A) |
| 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 | Number of Participants With Clinically Significant Effects | Clinically significant effects are study drug related serious adverse events (SAEs) and study drug related treatment emergent adverse events (TEAEs). A summary of all SAEs and all other non-SAEs regardless of causality is located in the Reported Adverse Events module. | All enrolled participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline to study completion up to 18.7 weeks |
|
Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
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 | 2 mg LY900009 - Dose Escalation Phase (Part A) | 2 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA(12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
| LY900009 - Dose Confirmation Phase (Part B) | Drug | 30 mg LY900009 orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle. Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met. |
|
|
| Predose up to 28 days in Cycle 1 |
| Percentage of Participants With a Best Overall Response of Stable Disease or Better (Document the Antitumor Activity) | Best overall response of stable disease or better is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.1). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Percentage of Participants with a best overall response of SD or better is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated then multiplied by 100. | Baseline to measured progressive disease up to 15.1 weeks |
| Pharmacokinetics: Area Under the Concentration-time Curve of LY900009 From Time Zero to Infinity [AUC(0-infinity)] | The geometric mean AUC(0-infinity) for each dose group is reported following a single dose of LY900009. | Day1: Pre-dose, 0.5 hours (hr), 1 hr, 3-4 hr, 6-8 hr and 24-30 hours post-dose |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY900009 | The geometric mean Cmax for each dose group is reported following a single dose of LY900009. | Day1: Pre-dose, 0.5 hours (hr), 1 hr, 3-4 hr, 6-8 hr and 24-30 hours post-dose |
| United States |
| 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. | Nashville | Tennessee | 37203 | United States |
| Physician Decision |
|
| Progressive Disease |
|
4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
| BG002 | 8 mg LY900009 - Dose Escalation Phase (Part A) | 8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| BG003 | 15 mg LY900009 - Dose Escalation Phase (Part A) | 15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| BG004 | 30 mg LY900009 - Dose Escalation Phase (Part A) | 30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| BG005 | 45 mg LY900009 - Dose Escalation Phase (Part A) | 45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| BG006 | 60 mg LY900009 - Dose Escalation Phase (Part A) | 60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| BG007 | 30 mg LY900009 - Dose Confirmation Phase (Part B) | 30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| OG002 | 8 mg LY900009 - Dose Escalation Phase (Part A) | 8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| OG003 | 15 mg LY900009 - Dose Escalation Phase (Part A) | 15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| OG004 | 30 mg LY900009 - Dose Escalation Phase (Part A) | 30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| OG005 | 45 mg LY900009 - Dose Escalation Phase (Part A) | 45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| OG006 | 60 mg LY900009 - Part A: Dose Escalation | 60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
| OG007 | 30 mg LY900009 - Dose Confirmation Phase (Part B) | 30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. |
|
|
| Secondary | Recommended Dose Range for Phase 2 Studies | Recommended Phase 2 dose was determined by the maximum tolerated dose (MTD). MTD is the highest dose with <33% of participants having a dose-limiting toxicity (DLT) during Cycle 1. DLT is an adverse event (AE) occurring for a participant enrolled in Part A that is likely related to the study drug and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 4.02) Grade 3 or 4 nonhematologic toxicity except for Grade 3 nausea, vomiting or electrolyte disturbance; Grade 3 nausea, vomiting or electrolyte disturbance that persists more than 2 days despite maximal supportive intervention; Grade 4 hematological toxicity that persists more than 5 days; Grade 3 or 4 thrombocytopenia with bleeding; Grade 3 or 4 neutropenia with fever. A DLT can be declared if a participant experiences increasing toxicity during treatment. | All enrolled participants who received at least one dose of study drug during dose escalation phase. | Posted | Number | milligrams (mg) | Predose up to 28 days in Cycle 1 |
|
|
|
| Secondary | Percentage of Participants With a Best Overall Response of Stable Disease or Better (Document the Antitumor Activity) | Best overall response of stable disease or better is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.1). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Percentage of Participants with a best overall response of SD or better is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated then multiplied by 100. | All enrolled participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline to measured progressive disease up to 15.1 weeks |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration-time Curve of LY900009 From Time Zero to Infinity [AUC(0-infinity)] | The geometric mean AUC(0-infinity) for each dose group is reported following a single dose of LY900009. | All enrolled participants who received the study drug and had sufficient pharmacokinetic (PK) data to calculate AUC(0-infinity). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliters (ng*h/mL) | Day1: Pre-dose, 0.5 hours (hr), 1 hr, 3-4 hr, 6-8 hr and 24-30 hours post-dose |
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY900009 | The geometric mean Cmax for each dose group is reported following a single dose of LY900009. | All enrolled participants who received the study drug and had sufficient pharmacokinetic (PK) data to calculate Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Day1: Pre-dose, 0.5 hours (hr), 1 hr, 3-4 hr, 6-8 hr and 24-30 hours post-dose |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | 4 mg LY900009 - Dose Escalation Phase (Part A) | 4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. | 1 | 4 | 3 | 4 |
| EG002 | 8 mg LY900009 - Dose Escalation Phase (Part A) | 8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. | 0 | 3 | 3 | 3 |
| EG003 | 15 mg LY900009 - Dose Escalation Phase (Part A) | 15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. | 1 | 3 | 3 | 3 |
| EG004 | 30 mg LY900009 - Dose Escalation/Confirmation Phase (Part A,B) | 30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. | 7 | 14 | 14 | 14 |
| EG005 | 45 mg LY900009 - Dose Escalation Phase (Part A) | 45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. | 3 | 5 | 5 | 5 |
| EG006 | 60 mg LY900009 - Dose Escalation Phase (Part A) | 60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle. | 2 | 3 | 3 | 3 |
| Nausea | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA(12.0) | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA(12.0) | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA(12.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA(12.0) | Systematic Assessment |
|
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA(12.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA(12.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA(12.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Tongue oedema | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA(12.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA(12.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA(12.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA(12.0) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA(12.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA(12.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA(12.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA(12.0) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA(12.0) | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA(12.0) | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA(12.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA(12.0) | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA(12.0) | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA(12.0) | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA(12.0) | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA(12.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA(12.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA(12.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA(12.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA(12.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA(12.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA(12.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA(12.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA(12.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA(12.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA(12.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA(12.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA(12.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA(12.0) | Systematic Assessment |
|
| Vitamin d deficiency | Metabolism and nutrition disorders | MedDRA(12.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA(12.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA(12.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA(12.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA(12.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA(12.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA(12.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA(12.0) | Systematic Assessment |
|
| Hyposmia | Nervous system disorders | MedDRA(12.0) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA(12.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA(12.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA(12.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA(12.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA(12.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA(12.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA(12.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA(12.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA(12.0) | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA(12.0) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA(12.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA(12.0) | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA(12.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA(12.0) | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA(12.0) | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA(12.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA(12.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA(12.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA(12.0) | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA(12.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA(12.0) | Systematic Assessment |
|
Not provided