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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
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The purpose of this Phase I/II study is to evaluate safety, pharmacokinetics, and preliminary efficacy of the investigational drug PLX3397 in subjects with unresectable or metastatic KIT-mutated melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLX3397 | Experimental | Part 1: Open label, multicenter study includes a dose evaluation portion in which the safety profile of PLX3397 as a single oral agent will be evaluated Part 2: An expansion cohort in which the efficacy and safety of PLX3397 administered at the recommended Phase 2 dose will be evaluated in patients with unresectable stage III or stage IV KIT-mutated melanoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLX3397 | Drug | 1000 mg/day (400 mg in the morning and 600 mg in the evening) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Best Overall Response Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | For the assessment of best overall response, participants were classified by RECIST v1.1: complete response (CR), disappearance of all target lesions and normalization of tumor marker level; partial response (PR), at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; stable disease (SD); neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study; progressive disease (PD), at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm; or not evaluable (NE) for analysis. | within 18 months postdose |
| Objective Response Rate (ORR) Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Objective response rate was defined as complete response (CR) or partial response (PR). | within 18 months postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Duration of Response (DoR) was defined as the time from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the first documentation of disease progression or to death due to any cause, whichever occurred first. DoR was to only be calculated for the subgroup of participants with an objective tumor response. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Sun Yat-sen Hospital |
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A total of 8 participants entered the pilot portion of the study; no participants entered the phase 2 portion. Of the 8 participants, 2 failed screening criteria and did not receive treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | PLX3397 | Participants who received PLX3397 1000 mg/day (400 mg in the morning and 600 mg in the evening). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | PLX3397 | Participants who received PLX3397 1000 mg/day (400 mg in the morning and 600 mg in the evening). |
| 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 | Summary of Best Overall Response Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | For the assessment of best overall response, participants were classified by RECIST v1.1: complete response (CR), disappearance of all target lesions and normalization of tumor marker level; partial response (PR), at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; stable disease (SD); neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study; progressive disease (PD), at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm; or not evaluable (NE) for analysis. | Best overall response was assessed in the Modified Intent-to-Treat Analysis Set. | Posted | Count of Participants | Participants | within 18 months postdose |
|
Adverse events were collected from after initiation of study drug up to 28 days after administration of last dose of study drug, up to 18 months postdose.
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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 | PLX3397 | Participants who received PLX3397 1000 mg/day (400 mg in the morning and 600 mg in the evening). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Face oedema | General disorders | MedDRA 21.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo, Inc. | 908-992-6400 | CTRinfo@dsi.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2020 | Mar 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000600259 | pexidartinib |
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| within 18 months postdose |
| Progression-free Survival Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Progression-free survival (PFS) was to be calculated for each participant as the number of days from study enrollment to the date of the first documented disease progression or date of death from any cause, whichever occurred first. | within 18 months postdose |
| Overall Survival Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Overall survival (OS) was defined as the time from study enrollment to death from any cause, censoring at the date of last contact or the end of the study. | within 18 months postdose |
| Disease Control Rate Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Disease control rate (DCR) was defined as the percentage of participants who had achieved complete response (CR), partial response (PR), or stable disease (SD). | within 18 months postdose |
| Summary of Pharmacokinetic Parameter of Maximum Concentration (Cmax) of PL3397 at Days 1 and 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma | Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose |
| Summary of Pharmacokinetic Parameter of Area Under the Curve From Zero to 6 Hours (AUC0-6) of PL3397 at Days 1 and 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma | Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose |
| Summary of Pharmacokinetic Parameter of Time to Maximum Concentration and Last Measurable Time of PL3397 at Days 1 and 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma | Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose |
| Summary of Pharmacokinetic Parameter of Accumulation Ratio of Day 15 to Day 1 for AUC0-6h (Robs) of PL3397 at Day 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma | Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose |
| Summary of Pharmacokinetic Parameter of Accumulation Ratio of Day 15 to Day 1 for Cmax (Rcmax) of PL3397 at Day 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma | Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose |
| Summary of Most Common (≥50% of Participants) Treatment-emergent Adverse Events Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | within 28 days after administration of the last dose of study drug, up to 18 months postdose |
| Summary of Treatment-emergent Adverse Events Grade ≥ 3 Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Grade ≥ 3 was used to indicate moderate-to-severe treatment-emergent adverse events in which moderate was defined as discomfort enough to cause interference with normal daily activities and severe defined as the inability to perform normal daily activities. | within 28 days after administration of the last dose of study drug, up to 18 months postdose |
| Summary of Most Common (≥50%) Drug-related Treatment-emergent Adverse Events Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | within 28 days after administration of the last dose of study drug, up to 18 months postdose |
| Summary of Drug-related Treatment-emergent Adverse Events Grade ≥ 3 Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Grade ≥ 3 was used to indicate moderate-to-severe treatment-emergent adverse events in which moderate was defined as discomfort enough to cause interference with normal daily activities and severe defined as the inability to perform normal daily activities. | within 28 days after administration of the last dose of study drug, up to 18 months postdose |
| Guangzhou |
| Guangdong |
| China |
| Samsung Medical Center | Seoul | Gangnam-Gu | 06351 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | Seodaemun-gu | 03722 | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | PLX3397 | Participants who received PLX3397 1000 mg/day (400 mg in the morning and 600 mg in the evening). |
|
|
| Primary | Objective Response Rate (ORR) Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Objective response rate was defined as complete response (CR) or partial response (PR). | Objective response rate among participants who achieved complete response or partial response was assessed in the Modified Intent-to-Treat Analysis Set. | Posted | Count of Participants | Participants | within 18 months postdose |
|
|
|
| Secondary | Duration of Response Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Duration of Response (DoR) was defined as the time from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the first documentation of disease progression or to death due to any cause, whichever occurred first. DoR was to only be calculated for the subgroup of participants with an objective tumor response. | Duration of response was assessed in the Modified Intent-to-Treat Analysis Set. | Posted | Median | Full Range | months | within 18 months postdose |
|
|
|
| Secondary | Progression-free Survival Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Progression-free survival (PFS) was to be calculated for each participant as the number of days from study enrollment to the date of the first documented disease progression or date of death from any cause, whichever occurred first. | Progression-free survival was assessed in the Modified Intent-to-Treat Analysis Set. | Posted | Median | 95% Confidence Interval | months | within 18 months postdose |
|
|
|
| Secondary | Overall Survival Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Overall survival (OS) was defined as the time from study enrollment to death from any cause, censoring at the date of last contact or the end of the study. | Overall survival was assessed in the Modified Intent-to-Treat Analysis Set. | Posted | Median | 95% Confidence Interval | months | within 18 months postdose |
|
|
|
| Secondary | Disease Control Rate Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Disease control rate (DCR) was defined as the percentage of participants who had achieved complete response (CR), partial response (PR), or stable disease (SD). | Disease control rate among participants who achieved CR, PR, or SD was assessed in the Modified Intent-to-Treat Analysis Set. | Posted | Count of Participants | Participants | within 18 months postdose |
|
|
|
| Secondary | Summary of Pharmacokinetic Parameter of Maximum Concentration (Cmax) of PL3397 at Days 1 and 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose |
|
|
|
| Secondary | Summary of Pharmacokinetic Parameter of Area Under the Curve From Zero to 6 Hours (AUC0-6) of PL3397 at Days 1 and 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | h*ng/mL | Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose |
|
|
|
| Secondary | Summary of Pharmacokinetic Parameter of Time to Maximum Concentration and Last Measurable Time of PL3397 at Days 1 and 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | hours | Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose |
|
|
|
| Secondary | Summary of Pharmacokinetic Parameter of Accumulation Ratio of Day 15 to Day 1 for AUC0-6h (Robs) of PL3397 at Day 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | Ratio | Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose |
|
|
|
| Secondary | Summary of Pharmacokinetic Parameter of Accumulation Ratio of Day 15 to Day 1 for Cmax (Rcmax) of PL3397 at Day 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | Ratio | Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose |
|
|
|
| Secondary | Summary of Most Common (≥50% of Participants) Treatment-emergent Adverse Events Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Safety events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | within 28 days after administration of the last dose of study drug, up to 18 months postdose |
|
|
|
| Secondary | Summary of Treatment-emergent Adverse Events Grade ≥ 3 Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Grade ≥ 3 was used to indicate moderate-to-severe treatment-emergent adverse events in which moderate was defined as discomfort enough to cause interference with normal daily activities and severe defined as the inability to perform normal daily activities. | Safety events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | within 28 days after administration of the last dose of study drug, up to 18 months postdose |
|
|
|
| Secondary | Summary of Most Common (≥50%) Drug-related Treatment-emergent Adverse Events Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Safety events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | within 28 days after administration of the last dose of study drug, up to 18 months postdose |
|
|
|
| Secondary | Summary of Drug-related Treatment-emergent Adverse Events Grade ≥ 3 Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma | Grade ≥ 3 was used to indicate moderate-to-severe treatment-emergent adverse events in which moderate was defined as discomfort enough to cause interference with normal daily activities and severe defined as the inability to perform normal daily activities. | Safety events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | within 28 days after administration of the last dose of study drug, up to 18 months postdose |
|
|
|
| 1 |
| 6 |
| 2 |
| 6 |
| 6 |
| 6 |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Total bile acids increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood creatinine phosphokinase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Urine ketone body present | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Alpha hydroxybutyrate dehydrogenase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood chloride decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood creatine phosphokinase MB increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| High density lipoprotein increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Albumin globulin ratio increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood magnesium increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Electrocardiogram high voltage | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Electrocardiogram ST-T change | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Mean cell volume abnormal | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Urobilinogen urine increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cervical polyp | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
Not provided
Not provided
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
|
|
|
| Last measurable time; Day 1 |
|
|
| Last measurable time; Day 15 |
|
|
| Title | Measurements |
|---|
|
| Face oedema |
|
| Alanine aminotransferase increased |
|
| Blood bilirubin increased |
|
| Gamma-glutamyltransferase increased |
|
| Hair colour changes |
|
| Neutrophil count decreased |
|
| Bilirubin conjugated increased |
|
| Blood alkaline phosphatase increased |
|
| Blood lactate dehydrogenase increased |
|
| Interstitial lung disease |
|
| Pyrexia |
|
| Total bile acids increased |
|
| Title | Measurements |
|---|---|
|
| Total bile acids increased |
|
| Anaemia |
|
| Aspartate aminotransferase increased |
|
| Bilirubin conjugated increased |
|
| Blood alkaline phosphatase increased |
|
| Blood bilirubin increased |
|
| Drug-induced liver injury |
|
| Herpes zoster |
|
| Hypertension |
|
| Neutrophil count decreased |
|
| White blood cell count decreased |
|
| Title | Measurements |
|---|
|
| Face oedema |
|
| Alanine aminotransferase increased |
|
| Blood bilirubin increased |
|
| Gamma-glutamyltransferase increased |
|
| Hair colour changes |
|
| Neutrophil count decreased |
|
| Bilirubin conjugated increased |
|
| Blood alkaline phosphatase increased |
|
| Blood lactate dehydrogenase increased |
|
| Interstitial lung disease |
|
| Total bile acids increased |
|
| Title | Measurements |
|---|---|
|
| Total bile acids increased |
|
| Aspartate aminotransferase increased |
|
| Bilirubin conjugated increased |
|
| Blood alkaline phosphatase increased |
|
| Blood bilirubin increased |
|
| Drug-induced liver injury |
|
| Neutrophil count decreased |
|
| White blood cell count decreased |
|