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| ID | Type | Description | Link |
|---|---|---|---|
| I5Z-MC-JKBA | Other Identifier | Eli Lilly and Company |
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This study evaluates the safety and tolerability of different doses of an experimental treatment in participants with advanced cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3007113 | Experimental | Study has a dose escalation phase (Part A) and dose confirmation phase (Part B). Participants in the dose escalation phase will receive 1 of 6 doses of LY3007113 administered orally every 12 hours for at least one cycle. Participants in the dose confirmation phase will receive the maximum tolerated dose from the dose escalation phase administered orally every 12 hours for at least 1 cycle. Three days prior to the start of the first cycle, participants will receive 1 dose at their assigned level to allow for the collection of single dose pharmacokinetics. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3007113 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests) | Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after randomization. A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. | Baseline through Study Completion (up to 170 Days) |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR) | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter without notable worsening of additional tumors that were qualitatively assessed. |
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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. | Santa Monica | California | 90404 |
For cohorts 1-3, participants completed the trial if they received at least 75% of planned doses of LY3007113 and completed at least 1 cycle. For Part B, participants completed the trial if they completed at least 2 cycles of study treatment and were assessed for response. (Cycle = 28 days.)
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| ID | Title | Description |
|---|---|---|
| FG000 | 20 mg LY3007113 (Cohort 1) | 20 milligrams (mg) LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit. |
| FG001 | 40 mg LY3007113 (Cohort 2) | 40 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit. |
| FG002 | 30 mg LY3007113 (Cohort 3) | 30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit. |
| FG003 | 30 mg LY3007113 (Part B) | 30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 20 mg LY3007113 (Cohort 1) | 20 mg LY3007113 administered once orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit. |
| BG001 | 40 mg LY3007113 (Cohort 2) |
| 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 | Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests) | Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after randomization. A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. | Participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through Study Completion (up to 170 Days) |
|
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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 | 20 mg LY3007113 (Cohort 1) | 20 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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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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| Baseline through Study Completion (up to 170 Days) |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of Single Dose LY3007113 | Cycle 1 Days -3, -2, -1, 1: Predose to 48 hours Postdose |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From 0 to Tau (AUC[0-tau]) of Multiple Dose LY3007113 | Cycle 1 Days 28 and 29, Cycle 2 Day 1: Predose to 24 hours Postdose |
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3007113 | Cycle 1 Day -3 (single dose): Predose to 48 hours Postdose; Day 28 (multiple dose): Predose to 24 hours Postdose |
| 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. | San Antonio | Texas | 78229 | United States |
| Death |
|
| Progressive Disease |
|
40 mg LY3007113 administered once orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit. |
| BG002 | 30 mg LY3007113 (Cohort 3) | 30 mg LY3007113 administered once orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit. |
| BG003 | 30 mg LY3007113 (Part B) | 30 mg LY3007113 administered once orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 40 mg LY3007113 (Cohort 2) | 40 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit. |
| OG002 | 30 mg LY3007113 (Cohort 3) | 30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit. |
| OG003 | 30 mg LY3007113 (Part B) | 30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit. |
|
|
| Secondary | The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR) | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter without notable worsening of additional tumors that were qualitatively assessed. | Participants in Part B who received at least one dose of study drug and were radiologically assessed for tumor response. | Posted | Number | percentage of participants | Baseline through Study Completion (up to 170 Days) |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of Single Dose LY3007113 | Participants who received at least one dose of study drug and had sufficient evaluable AUC(0-inf) values. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter (ng*hr/mL) | Cycle 1 Days -3, -2, -1, 1: Predose to 48 hours Postdose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From 0 to Tau (AUC[0-tau]) of Multiple Dose LY3007113 | Participants who received at least one dose of study drug and had sufficient evaluable AUC(0-tau) values. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Cycle 1 Days 28 and 29, Cycle 2 Day 1: Predose to 24 hours Postdose |
|
|
|
| Secondary | Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3007113 | Participants who received at least one dose of study drug and had sufficient evaluable Cmax values. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1 Day -3 (single dose): Predose to 48 hours Postdose; Day 28 (multiple dose): Predose to 24 hours Postdose |
|
|
|
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | 40 mg LY3007113 (Cohort 2) | 40 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit. | 1 | 4 | 4 | 4 |
| EG002 | 30 mg LY3007113 (Cohort 3) | 30 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit. | 2 | 5 | 5 | 5 |
| EG003 | 30 mg LY3007113 (Part B) | 30 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit. | 5 | 15 | 14 | 15 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
|
| Blindness unilateral | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Retinal degeneration | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Anal inflammation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Feeling jittery | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Lip infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Incision site rash | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
Not provided
| Multiple dose |
|
|