Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I5B-EW-JGDI | Other Identifier | Eli Lilly and Company |
Not provided
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The purpose of this study is to assess how the body handles olaratumab when it is given with another drug called doxorubicin.
The safety and tolerability of these drugs will be studied. Each participant will complete two 21-day cycles in a fixed order. Participants who complete Cycle 2 may continue to receive olaratumab + doxorubicin for an additional six 21-day cycles and then may receive olaratumab alone until discontinuation criteria are met.
Screening is required within 21 days prior to first dose.
Part B was added in October, 2015 to assess how the body handles a higher dose of olaratumab when given with doxorubicin.
Participants may only enroll in one part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV). Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV. Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met. |
|
| Part B | Experimental | Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV. Olaratumab + Doxorubicin: For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaratumab | Drug | Administered IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) Doxorubicin | Cycle(C)1 and (C)2, Day(D)1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hours (Hrs) Post dose | |
| PK: Maximum Concentration (Cmax) Doxorubicin | C1 and C2, D1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hrs Post dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK:Time of Maximum Observed Concentration (Tmax) Doxorubicin | C1 and C2, D1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hrs Post dose | |
| PK: AUC Zero to Time t, Where t is the Last Time Point (0-tLast) Olaratumab | PK: AUC (0-tLast) with a measurable concentration. PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | United States | ||
| University of Colorado Cancer Center |
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Completers include participants who died or discontinued study treatment due to progressive disease.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A | Doxorubicin (Dox) Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV). Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV. Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met. |
| FG001 | Part B | Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV. Olaratumab + Doxorubicin: For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A | Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV). Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV. Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met. |
| 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 | Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) Doxorubicin | All participants who received at least one dose of study drugs and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter (ng*h/mL) | Cycle(C)1 and (C)2, Day(D)1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hours (Hrs) Post dose |
|
From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
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 | Part A | Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV). Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV. Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589393 | olaratumab |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
| Doxorubicin | Drug | Administered IV |
|
| C1 D10: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose |
| PK: Cmax Olaratumab | PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin. | C1 D10:Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose |
| PK: Tmax Olaratumab | Tmax times are relative to the start of the approximately 60-minute IV infusion of olaratumab. PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin. | C1 D10: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose |
| Percentage of Participants With Olaratumab Antibodies | The formation of anti-drug antibodies (ADA) was assessed using validated ELISAs, following a 4-tier approach. Both the ADA screening assay and the neutralizing antibody assay were validated in accordance with the US Food and Drug Administration (FDA) Guidance for Industry. Participants who had positive samples for treatment emergence due to being <4-fold difference from baseline or occurred prior to drug exposure are reported. | Preinfusion on Day 1 of Cycles 1 through 3 and Preinfusion on Day 1 of Every Second Cycle Thereafter, Up to 30-Day Follow Up |
| Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | The percentage of participants with a best overall response achieving CR or PR (ORR) was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions. The methodology for the confidence interval calculation is the "exact F" method. | Baseline to Measured Progressive Disease, Study Discontinuation or Death (Up to 24 Months) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| IU Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Physician and Participant Decision |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG001 | Part B | Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV. Olaratumab + Doxorubicin: For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met. |
| BG002 | 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 |
|
| OG002 | Part B Doxorubicin Alone | On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV |
| OG003 | Part B Doxorubicin + 20 mg/kg Olaratumab | On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion. |
|
|
|
| Primary | PK: Maximum Concentration (Cmax) Doxorubicin | All participants who received at least one dose of study drugs and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/ml) | C1 and C2, D1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hrs Post dose |
|
|
|
|
| Secondary | PK:Time of Maximum Observed Concentration (Tmax) Doxorubicin | All participants who received at least one dose of study drugs and had evaluable PK data. | Posted | Median | Full Range | hour (h) | C1 and C2, D1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hrs Post dose |
|
|
|
| Secondary | PK: AUC Zero to Time t, Where t is the Last Time Point (0-tLast) Olaratumab | PK: AUC (0-tLast) with a measurable concentration. PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin. | All participants who received at least one dose of study drugs and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng∙h/mL | C1 D10: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose |
|
|
|
| Secondary | PK: Cmax Olaratumab | PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin. | All participants who received at least one dose of study drugs and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | C1 D10:Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose |
|
|
|
| Secondary | PK: Tmax Olaratumab | Tmax times are relative to the start of the approximately 60-minute IV infusion of olaratumab. PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin. | All participants who received at least one dose of study drugs and had evaluable PK data. | Posted | Median | Full Range | h | C1 D10: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose |
|
|
|
| Secondary | Percentage of Participants With Olaratumab Antibodies | The formation of anti-drug antibodies (ADA) was assessed using validated ELISAs, following a 4-tier approach. Both the ADA screening assay and the neutralizing antibody assay were validated in accordance with the US Food and Drug Administration (FDA) Guidance for Industry. Participants who had positive samples for treatment emergence due to being <4-fold difference from baseline or occurred prior to drug exposure are reported. | All participants who received at least one dose of study drug and had evaluable baseline and post-baseline anti-olaratumab antibodies. | Posted | Number | percentage of participants | Preinfusion on Day 1 of Cycles 1 through 3 and Preinfusion on Day 1 of Every Second Cycle Thereafter, Up to 30-Day Follow Up |
|
|
|
| Secondary | Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | The percentage of participants with a best overall response achieving CR or PR (ORR) was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions. The methodology for the confidence interval calculation is the "exact F" method. | All participants who received at least one dose of study drug and had a post-baseline lesion response. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Measured Progressive Disease, Study Discontinuation or Death (Up to 24 Months) |
|
|
|
| 9 |
| 25 |
| 24 |
| 25 |
| EG001 | Part B | Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV. Olaratumab + Doxorubicin: For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met. | 9 | 24 | 24 | 24 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Gastroenteritis salmonella | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Embolism venous | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Temperature intolerance | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
Not provided
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| Ratio of LS Means |
| 1.03 |
| 2-Sided |
| 90 |
| 0.801 |
| 1.33 |
| Superiority |