Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H8K-MC-JZAG | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to determine whether LY573636-sodium (hereafter referred to as LY573636) is effective in treating platinum-resistant ovarian cancer. Patients will receive an intravenous infusion of study drug once every 28 days. Computed tomography (CT) scans and CA-125 tests will be done before the first dose and then after every other treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY573636 | Experimental | LY573636-sodium (LY573636) is administered every 28 days until disease progression or other criteria for participant discontinuation are met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY573636-sodium | Drug | LY573636 dose is dependent on participant's height, weight, and gender and is adjusted to target a specific maximum concentration (Cmax) based on participant laboratory parameters. LY573636 is administered every 28 days until disease progression or other criteria for participant discontinuation are met. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response and Partial Response (Objective Response Rate) | Objective response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | Baseline to measured progressive disease up to 12.68 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | Baseline to measured progressive disease or death due to any cause up to 21.26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment | Study treatment discontinuation up to 30 days post study treatment discontinuation |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | Scottsdale | Arizona | 85258 |
The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have "completed" the trial if they experienced progressive disease or an adverse event.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Target Cmax 420 µg/mL | Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle. |
| FG001 | Target Cmax 360 μg/mL | Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle. |
| FG002 | Albumin-Tailored Dose | The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who had at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Target Cmax 420 µg/mL | Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle. |
| BG001 |
| 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 | Percentage of Participants With Complete Response and Partial Response (Objective Response Rate) | Objective response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | All participants who received at least one dose of the study drug. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to measured progressive disease up to 12.68 months |
|
Not provided
Deaths due to progressive disease are not considered adverse events; however they are reported in the participant flow for those who died during the study and in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
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 | Target Cmax 420 µg/mL | Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C534068 | N-((5-bromo-2-thienyl)sulfonyl)-2,4-dichlorobenzamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Percentage of Participants With Complete Response, Partial Response, and Stable Disease (Clinical Benefit Rate) | Clinical Benefit Rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated multiplied by 100. | Baseline to measured progressive disease up to 21.26 months |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 | Predose up to 2 hours postdose in Cycles 1 and 2 |
| Overall Survival | Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact. | First treatment to death due to any cause up to 42.91 months |
| Duration of Response | The duration of response (complete response [CR] or partial response [PR]) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. | Time of response to time of measured progressive disease up to 12.68 months |
| Duration of Stable Disease | Duration of stable disease is defined from date of documented stable disease (SD) or better to first date of progressive disease or death from any cause (assessed every cycle during study therapy, or every 2 months during post-therapy until disease progression or death). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | Time from documented SD or better to first date of progressive disease or death due to any cause up to 21.26 months |
| Number of Participants With Adverse Events (Safety) | Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. | First treatment dose up to 43.91 months |
| 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. | Aurora | Colorado | 80045 | 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. | Chicago | Illinois | 60637 | 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. | New York | New York | 10021 | 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. | Oklahoma City | Oklahoma | 73104 | 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. | Brescia | 25123 | Italy |
| 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. | Rome | 00168 | Italy |
| 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. | Moscow | 115478 | Russia |
| Adverse Event |
|
| Investigator Decision |
|
| Progressive Disease |
|
| Withdrawal by Subject |
|
| Target Cmax 360 μg/mL |
Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle. |
| BG002 | Albumin-Tailored Dose | The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Target Cmax 360 μg/mL | Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle. |
| OG002 | Albumin-Tailored Dose | The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle. |
|
|
| Secondary | Progression Free Survival | Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | All participants who received at least 1 dose of the study drug. | Posted | Median | 90% Confidence Interval | months | Baseline to measured progressive disease or death due to any cause up to 21.26 months |
|
|
|
| Secondary | Percentage of Participants With Complete Response, Partial Response, and Stable Disease (Clinical Benefit Rate) | Clinical Benefit Rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated multiplied by 100. | All participants who received at least one dose of the study drug. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to measured progressive disease up to 21.26 months |
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 | All participants who received at least one dose of the study drug and had pharmacokinetics data at the specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter (µg/mL) | Predose up to 2 hours postdose in Cycles 1 and 2 |
|
|
|
| Secondary | Overall Survival | Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact. | All participants who received at least one dose of the study drug. The numbers of participants censored are 11 (Target Cmax 420 µg/mL group), 6 (Target Cmax 360 µg/mL group) and 14 (Albumin-Tailored Dose group). | Posted | Median | 90% Confidence Interval | months | First treatment to death due to any cause up to 42.91 months |
|
|
|
| Secondary | Duration of Response | The duration of response (complete response [CR] or partial response [PR]) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. | All participants who received at least one dose of the study drug and had complete response (CR) or partial response (PR). | Posted | Median | 90% Confidence Interval | months | Time of response to time of measured progressive disease up to 12.68 months |
|
|
|
| Secondary | Duration of Stable Disease | Duration of stable disease is defined from date of documented stable disease (SD) or better to first date of progressive disease or death from any cause (assessed every cycle during study therapy, or every 2 months during post-therapy until disease progression or death). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | All participants who received at least one dose of the study drug and stable disease or better. | Posted | Median | 90% Confidence Interval | months | Time from documented SD or better to first date of progressive disease or death due to any cause up to 21.26 months |
|
|
|
| Secondary | Number of Participants With Adverse Events (Safety) | Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. | All participants who received at least one dose of the study drug. | Posted | Count of Participants | Participants | No | First treatment dose up to 43.91 months |
|
|
|
| Other Pre-specified | Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment | All participants who received at least one dose of the study drug. | Posted | Count of Participants | Participants | No | Study treatment discontinuation up to 30 days post study treatment discontinuation |
|
|
|
| 21 |
| 53 |
| 47 |
| 53 |
| EG001 | Target Cmax 360 μg/mL | Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle. | 5 | 18 | 18 | 18 |
| EG002 | Albumin-Tailored Dose | The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle. | 15 | 32 | 30 | 32 |
| Febrile neutropenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment | Resulted in 1 death in the Albumin-Tailored Dose arm. |
|
| Atrial fibrillation | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | 14.1 | Systematic Assessment | Resulted in 1 death in the Albumin-Tailored Dose arm. |
|
| Cardiac failure | Cardiac disorders | 14.1 | Systematic Assessment | Resulted in 1 death in the Target Cmax 420 µg/mL arm. |
|
| Pericardial effusion | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 14.1 | Systematic Assessment | Resulted in 1 death in the Target Cmax 420 µg/mL arm. |
|
| Intestinal obstruction | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | 14.1 | Systematic Assessment | Resulted in 1 death in the Target Cmax 420 µg/mL arm within 30 days of discontinuation from study treatment. |
|
| Mouth haemorrhage | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Hyperpyrexia | General disorders | 14.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | 14.1 | Systematic Assessment |
|
| Hepatic haemorrhage | Hepatobiliary disorders | 14.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | 14.1 | Systematic Assessment |
|
| Abscess intestinal | Infections and infestations | 14.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | 14.1 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | 14.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | 14.1 | Systematic Assessment |
|
| Empyema | Infections and infestations | 14.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | 14.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 14.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | 14.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | 14.1 | Systematic Assessment | Resulted in 1 death in the Albumin-Tailored Dose arm. |
|
| Staphylococcal sepsis | Infections and infestations | 14.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | 14.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | 14.1 | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | 14.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | 14.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment | Resulted in 1 death in the Target Cmax 420 µg/mL arm. |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment | Resulted in 1 death in the Target Cmax 420 µg/mL arm within 30 days of discontinuation from study treatment. |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment | Resulted in 1 death in the Albumin-Tailored Dose arm. |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment | Resulted in 1 death in the Albumin-Tailored Dose arm. |
|
| Hypertension | Vascular disorders | 14.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | 14.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | 14.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | 14.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | 14.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Abdominal mass | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Asthenia | General disorders | 14.1 | Systematic Assessment |
|
| Chills | General disorders | 14.1 | Systematic Assessment |
|
| Early satiety | General disorders | 14.1 | Systematic Assessment |
|
| Fatigue | General disorders | 14.1 | Systematic Assessment |
|
| Injection site pain | General disorders | 14.1 | Systematic Assessment |
|
| Malaise | General disorders | 14.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | 14.1 | Systematic Assessment |
|
| Pain | General disorders | 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | 14.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | 14.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | 14.1 | Systematic Assessment |
|
| Ear lobe infection | Infections and infestations | 14.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | 14.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | 14.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | 14.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | 14.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | 14.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | 14.1 | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | 14.1 | Systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | 14.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | 14.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | 14.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | 14.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | 14.1 | Systematic Assessment |
|
| Body temperature | Investigations | 14.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | 14.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | 14.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | 14.1 | Systematic Assessment |
|
| Weight decreased | Investigations | 14.1 | Systematic Assessment |
|
| Weight increased | Investigations | 14.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | 14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 14.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | 14.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | 14.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | 14.1 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | 14.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | 14.1 | Systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | 14.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | 14.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | 14.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | 14.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | 14.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | 14.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | 14.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | 14.1 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | 14.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | 14.1 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | 14.1 | Systematic Assessment |
|
| Raynaud's phenomenon | Vascular disorders | 14.1 | Systematic Assessment |
|
Not provided
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| Cycle 2 |
|
|
|