Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| AURA-001 | Other Identifier | AurKa Pharma Inc. | |
| J1O-MC-JZHA | Other Identifier | Eli Lilly and Company |
Not provided
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| Name | Class |
|---|---|
| AurKa Pharma Inc. | OTHER |
Not provided
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This two-part study consists of a phase 1 dose escalation study in participants with locally advanced or metastatic solid tumors, and a phase 2 portion in up to 3 groups with either small cell lung cancer, breast cancer and/or one other solid tumor type.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 milligrams (mg) LY3295668 (Phase 1) | Experimental | 25 milligrams (mg) LY3295668 twice daily (BID) administered orally in 21-day cycles. |
|
| 50 mg LY3295668 (Phase 1) | Experimental | 50 mg LY3295668 BID administered orally in 21-day cycles. |
|
| 75 mg LY3295668 (Phase 1) | Experimental | 75 mg LY3295668 BID administered orally in 21-day cycles. |
|
| 25 mg LY3295668 (Phase 2) | Experimental | 25 mg LY3295668 BID administered orally in 21-day cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3295668 | Drug | Oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Maximum Tolerated Dose | Maximum Tolerated Dose (MTD) was defined as the dose immediately below the dose at which ≥2/3, ≥2/6, or ≥3/9 participants in a cohort experienced a dose limiting toxicity (DLT) during the first 21 days of treatment (Cycle 1) in Phase 1. | Cycle 1 (21 days) |
| Phase 2: Percentage of Participants Who Achieved Partial Response (PR) or Complete Response (CR) [Objective Response Rate (ORR)] | Objective response rate (ORR) was defined as a percentage of responders who achieved complete response or partial response (CR+PR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and no appearance of new lesion. Partial response (PR) was defined as at least a 30% decrease in the sum of longest diameters (LD) of target lesions, taking as reference the baseline sum of LD, no progression of non-target lesions, and no appearance of new lesions. | Baseline to Objective Disease Progression (Up to 11 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Participants With One or More Treatment-Emergent Adverse Events | A treatment-emergent adverse event (AE) is an AE that started or worsened (increased in severity) from the treatment start date to 30 days after the treatment end date. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section. |
Not provided
Inclusion Criteria:
Phase 1
Phase 2
Have disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
Have evidence of a solid tumor that is locally advanced and/or metastatic, and in:
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 |
|---|---|---|---|---|---|---|
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada | ||
| Jewish General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33479856 | Derived | Chu QS, Bouganim N, Fortier C, Zaknoen S, Stille JR, Kremer JD, Yuen E, Hui YH, de la Pena A, Lithio A, Smith PS, Batist G. Aurora kinase A inhibitor, LY3295668 erbumine: a phase 1 monotherapy safety study in patients with locally advanced or metastatic solid tumors. Invest New Drugs. 2021 Aug;39(4):1001-1010. doi: 10.1007/s10637-020-01049-3. Epub 2021 Jan 22. |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Phase I participants are said to have completed the study if they completed Dose Limiting Toxicity (DLT) period or have had a DLT. Phase II participants who died or are alive and on study at conclusion but off treatment are defined as completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | 25 Milligrams (mg) LY3295668 (Phase 1) | 25 mg LY3295668 twice daily (BID) administered orally in 21-day cycles. |
| FG001 | 50 mg LY3295668 (Phase 1) | 50 mg LY3295668 BID administered orally in 21-day cycles. |
| FG002 | 75 mg LY3295668 (Phase 1) | 75 mg LY3295668 BID administered orally in 21-day cycles. |
| FG003 | 25 mg LY3295668 (Phase 2) | 25 mg LY3295668 BID administered orally in 21-day cycles. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 25 Milligrams (mg) LY3295668 (Phase 1) | 25 mg LY3295668 twice daily (BID) administered orally in 21-day cycles. |
| BG001 | 50 mg LY3295668 (Phase 1) | 50 milligrams (mg) LY3295668 BID administered orally in 21-day cycles. LY3295668: Oral capsules |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1: Maximum Tolerated Dose | Maximum Tolerated Dose (MTD) was defined as the dose immediately below the dose at which ≥2/3, ≥2/6, or ≥3/9 participants in a cohort experienced a dose limiting toxicity (DLT) during the first 21 days of treatment (Cycle 1) in Phase 1. | All participants who received at least one dose of study drug and experienced a DLT; or received ≥ 38 doses of study drug in Cycle 1 and were not discontinued from the study before completing Cycle 1. | Posted | Number | milligram (mg) | Cycle 1 (21 days) |
|
Up to 29 Months
All participants who received at least one dose of study drug, whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
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 | 25 Milligrams (mg) LY3295668 | 25 mg LY3295668 BID administered orally in 21-day cycles. Phase 1 and Phase 2 participants have been combined. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
Study terminated due to sponsor decision.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-595-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2018 | Apr 12, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2019 | Apr 12, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| D064726 | Triple Negative Breast Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D001943 | Breast Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000722208 | LY3295668 erbumine |
Not provided
Not provided
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Open-Label
Not provided
|
| Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months) |
| Phase 2: Number of Participants With One or More Treatment-Emergent Adverse Events | A treatment-emergent adverse event (AE) is an AE that started or worsened (increased in severity) from the treatment start date to 30 days after the treatment end date. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section. | Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months) |
| Phase 2: Pharmacokinetic (PK): Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC[0-12]) (Phase 2) | Area under the plasma concentration-time curve for LY3295668 from time zero to 12 hours. | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 - 12 hours postdose; Cycle 1: Day 2 and Day 8 predose |
| Phase 2: PK: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-dose (AUC[0-24]) | Area under the plasma concentration-time curve for LY3295668 from time zero to 24 hours. | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8-12 hours post-dose; Cycle 1: Day 2 and Day 8 Predose |
| Phase 2: PK: Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration for LY3295668. | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 hours post-dose |
| Phase 2: PK: Time of Maximum Observed Plasma Concentration (Tmax) | Time of maximum observed plasma concentration of LY3295668. | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 hours post-dose |
| Phase 2: PK: Apparent Terminal Elimination Half-life (t1/2) | Apparent terminal elimination half-life of LY3295668. | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8-12 hours post-dose; Cycle 1: Day 2 and Day 8 Predose |
| Phase 2: PK: Apparent Total Plasma Clearance (CL/F) | Apparent total plasma clearance of LY3295668. | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 -12 hours post-dose; Cycle 1: Day 2 and Day 8 Predose |
| Phase 2: PK: Apparent Volume of Distribution (Vz/F) | Apparent volume of distribution of LY3295668. | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 -12 hours post-dose; Cycle 1: Day 2 and Day 8 Predose |
| Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 White Blood Cell Count (WBC) | Presented are participants with the worst post-baseline WBC Grade >= 3 using the National Cancer Institute (NCI) Common Terminology Criteria For Adverse Events version 4.03 (CTCAE v4.03). where Grade 1: < Lower Limit Normal (LLN) - 3000/mm3; \ | Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months) |
| Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 Neutrophils (Segmented and Blended) | Presented are participants with the worst post-baseline neutrophils Grade >=3 using the NCI-CTCAE v4.03 where Grade 1: < LLN - 1500/mm3; \ | Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months) |
| Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 Lymphocytes | Presented are participants with the worst post-baseline lymphocytes Grade >=3 using the NCI-CTCAE version 4.03 where Grade 1: \ | Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months) |
| Montreal |
| Quebec |
| H3T 1E2 |
| Canada |
| McGill University | Montreal | Quebec | H4A 3J1 | Canada |
| BG002 | 75 mg LY3295668 (Phase 1) | 75 mg LY3295668 BID administered orally in 21-day cycles. LY3295668: Oral capsules |
| BG003 | 25 mg LY3295668 (Phase 2) | 25 mg LY3295668 BID administered orally in 21-day cycles. LY3295668: Oral capsules |
| BG004 | Total | Total of all reporting groups |
| Participants |
| No |
|
| 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 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Phase 2: Percentage of Participants Who Achieved Partial Response (PR) or Complete Response (CR) [Objective Response Rate (ORR)] | Objective response rate (ORR) was defined as a percentage of responders who achieved complete response or partial response (CR+PR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and no appearance of new lesion. Partial response (PR) was defined as at least a 30% decrease in the sum of longest diameters (LD) of target lesions, taking as reference the baseline sum of LD, no progression of non-target lesions, and no appearance of new lesions. | All patients who received at least 1 dose of AK-01, whether or not they completed all protocol requirements. | Posted | Number | percentage of participants | Baseline to Objective Disease Progression (Up to 11 months) |
|
|
|
| Secondary | Phase 1: Number of Participants With One or More Treatment-Emergent Adverse Events | A treatment-emergent adverse event (AE) is an AE that started or worsened (increased in severity) from the treatment start date to 30 days after the treatment end date. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section. | All participants who received at least one dose of study drug, whether or not they completed all protocol requirements. | Posted | Count of Participants | Participants | No | Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months) |
|
|
|
| Secondary | Phase 2: Number of Participants With One or More Treatment-Emergent Adverse Events | A treatment-emergent adverse event (AE) is an AE that started or worsened (increased in severity) from the treatment start date to 30 days after the treatment end date. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section. | All participants who received at least one dose of study drug whether or not they completed all protocol requirements. | Posted | Count of Participants | Participants | No | Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months) |
|
|
|
| Secondary | Phase 2: Pharmacokinetic (PK): Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC[0-12]) (Phase 2) | Area under the plasma concentration-time curve for LY3295668 from time zero to 12 hours. | Zero participants analyzed due to data not collected. | Posted | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 - 12 hours postdose; Cycle 1: Day 2 and Day 8 predose |
|
|
| Secondary | Phase 2: PK: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-dose (AUC[0-24]) | Area under the plasma concentration-time curve for LY3295668 from time zero to 24 hours. | Zero participants analyzed due to data not collected. | Posted | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8-12 hours post-dose; Cycle 1: Day 2 and Day 8 Predose |
|
|
| Secondary | Phase 2: PK: Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration for LY3295668. | All participants who received at least one dose of study drug and had evaluable PK data in Phase 2 per protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per liter (µg/L) | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 hours post-dose |
|
|
|
| Secondary | Phase 2: PK: Time of Maximum Observed Plasma Concentration (Tmax) | Time of maximum observed plasma concentration of LY3295668. | All participants who received at least one dose of study drug and had evaluable PK data in Phase 2 per protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 hours post-dose |
|
|
|
| Secondary | Phase 2: PK: Apparent Terminal Elimination Half-life (t1/2) | Apparent terminal elimination half-life of LY3295668. | Zero participants analyzed due to data not collected. | Posted | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8-12 hours post-dose; Cycle 1: Day 2 and Day 8 Predose |
|
|
| Secondary | Phase 2: PK: Apparent Total Plasma Clearance (CL/F) | Apparent total plasma clearance of LY3295668. | Zero participants analyzed due to data not collected. | Posted | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 -12 hours post-dose; Cycle 1: Day 2 and Day 8 Predose |
|
|
| Secondary | Phase 2: PK: Apparent Volume of Distribution (Vz/F) | Apparent volume of distribution of LY3295668. | Zero participants analyzed due to data not collected. | Posted | Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 -12 hours post-dose; Cycle 1: Day 2 and Day 8 Predose |
|
|
| Secondary | Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 White Blood Cell Count (WBC) | Presented are participants with the worst post-baseline WBC Grade >= 3 using the National Cancer Institute (NCI) Common Terminology Criteria For Adverse Events version 4.03 (CTCAE v4.03). where Grade 1: < Lower Limit Normal (LLN) - 3000/mm3; \ | All participants who received at least one dose of study drug, whether or not they completed all protocol requirements in Phase 1 per protocol. | Posted | Count of Participants | Participants | No | Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months) |
|
|
|
| Secondary | Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 Neutrophils (Segmented and Blended) | Presented are participants with the worst post-baseline neutrophils Grade >=3 using the NCI-CTCAE v4.03 where Grade 1: < LLN - 1500/mm3; \ | All participants who received at least one dose of study drug, whether or not they completed all protocol requirements in Phase 1 per protocol. | Posted | Count of Participants | Participants | No | Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months) |
|
|
|
| Secondary | Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 Lymphocytes | Presented are participants with the worst post-baseline lymphocytes Grade >=3 using the NCI-CTCAE version 4.03 where Grade 1: \ | All participants who received at least one dose of study drug, whether or not they completed all protocol requirements in Phase 1 per protocol. | Posted | Count of Participants | Participants | No | Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months) |
|
|
|
| 1 |
| 9 |
| 4 |
| 9 |
| 9 |
| 9 |
| EG001 | 50 mg LY3295688 | 50 mg LY3295668 BID administered orally in 21-day cycles. | 0 | 2 | 1 | 2 | 2 | 2 |
| EG002 | 75 mg LY3295688 | 75 mg LY3295668 BID administered orally in 21-day cycles | 0 | 2 | 2 | 2 | 2 | 2 |
| Corneal deposits | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Night blindness | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gingival recession | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Urinary hesitation | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
Not provided
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |