An Efficacy and Safety Study for Yondelis (Trabectedin) i... | NCT00113607

NCT00113607

ID	Type	Description	Link
ET743-OVA-301	Other Identifier	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2004-005276-16	EudraCT Number

Status Module

Name	Class
PharmaMar	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DOXIL + trabectedin	Experimental	Combination arm - Trabectedin + DOXIL: DOXIL 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks. patients will be premedicated with 20 mg dexamethasone or its equivalent IV infusion over 30 minutes prior to the DOXIL infusion.	Drug: Trabectedin Drug: DOXIL Drug: Dexamethasone
DOXIL	Active Comparator	Monotherapy arm - DOXIL: 50 mg/m2 IV infusion over 90 minutes every 4 weeks.	Drug: DOXIL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trabectedin	Drug	Type=exact number, unit=mg/m2, number=1.1, form=solution, route=IV. Trabectedin will be administered over 3 hours every 3 weeks.	DOXIL + trabectedin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS): Independent Radiologist Review	PFS is defined as the time between randomization and disease progression or death.	From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall survival was defined as the time between the randomization and death	From the date of randomization until the date of death, as assessed for approximately 3 years
Objective Response Rate (ORR) - Independent Radiologist Review

Eligibility Module

Name	Affiliation	Role
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37407274	Derived	Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
33960681	Derived	Jones RL, Herzog TJ, Patel SR, von Mehren M, Schuetze SM, Van Tine BA, Coleman RL, Knoblauch R, Triantos S, Hu P, Shalaby W, McGowan T, Monk BJ, Demetri GD. Cardiac safety of trabectedin monotherapy or in combination with pegylated liposomal doxorubicin in patients with sarcomas and ovarian cancer. Cancer Med. 2021 Jun;10(11):3565-3574. doi: 10.1002/cam4.3903. Epub 2021 May 7.

Label	URL
Monk BJ, Herzog TJ, Kaye SB, Krasner CN, Vermorken JB, Muggia FM, Pujade-Lauraine E, Lisyanskaya AS, Makhson AN, Rolski J, Gorbounova VA, Ghatage P, Bidzinski M, Shen K, Ngan HY, Vergote IB, Nam JH, Park YC, Lebedinsky CA, Poveda AM.	View source

ID	Title	Description
FG000	DOXIL	50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
FG001	Trabectedin/DOXIL	30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks

Categories

Title	Measurements
	BG00058.2± 10.75 BG00156.8± 10.48 BG00257.5± 10.63

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000335 BG001337 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG0005 BG0012 BG002

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

Progression-Free Survival (PFS): Independent Radiologist Review

PFS is defined as the time between randomization and disease progression or death.

All Measurable Analysis Participants: All randomized participants who had measurable disease at baseline as assessed by the independent radiology review. Measurable disease is defined as having at least 1 lesion measured with a diameter of ≥20 mm using conventional techniques or of ≥10 mm using a spiral computerized tomography scan.

Posted

Median

95% Confidence Interval

Months

From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years

ID	Title	Description
OG000	DOXIL	50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
OG001	Trabectedin/DOXIL	30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks

Units	Counts
Participants	OG000317 OG001328

Title

Denominators

Categories

Title	Measurements
	OG0005.8(5.5 to 7.1) OG0017.3(5.9 to 7.9)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.0190		Hazard Ratio, log	0.79			2-Sided	95	0.65	0.96				No	Superiority or Other

Secondary

Overall Survival

Overall survival was defined as the time between the randomization and death

All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not

Posted

Median

95% Confidence Interval

Months

From the date of randomization until the date of death, as assessed for approximately 3 years

ID	Title	Description
OG000	DOXIL	50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
OG001	Trabectedin/DOXIL	30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks

Units	Counts
Participants	OG000

Secondary

Objective Response Rate (ORR) - Independent Radiologist Review

Percentage of participants who achieved complete response (CR) or partial response (PR) as best overall response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR)= greater than or equal to 30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.

All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not.

Posted

Number

Percentage of participants

From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years

ID	Title	Description
OG000	DOXIL	50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
OG001	Trabectedin/DOXIL	30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks

Units	Counts
Participants

Secondary

Duration of Response: Independent Radiologist Review

Duration of response was defined only for participants who had complete response or partial response as best overall response. Duration of response was calculated from the date of first documentation of response (not the confirmation) to the date of disease progression or death due to progressive disease.

All Responders (CR/PR) Analysis Participants: all participants who achieved CR or PR as best overall response during the study.

Posted

Median

95% Confidence Interval

Months

From the date of first documentation of response to the date of disease progression or death due to progressive disease, as assessed for approximately 3 years

ID	Title	Description
OG000	DOXIL	50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
OG001	Trabectedin/DOXIL	30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks

Units	Counts
Participants

Secondary

Median Area Under Curve (AUC) of Trabectedin.

Median simulated area under the curve (AUC) of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil, calculated using the trapezoidal rule method. Simulations were based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (Participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.

Blood samples for pharmacokinetic analysis were collected from 86 participants of this study.

Posted

Number

ng*h/mL

Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2

ID	Title	Description
OG000	Trabectedin/DOXIL	30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks

Units	Counts
Participants	OG000

Secondary

Median Maximum Plasma Concentration (Cmax) of Trabectedin.

Median simulated maximum plasma concentration (Cmax) at 3 hour of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil. The assessment of Cmax was based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.

Blood samples for pharmacokinetic analysis were collected from 86 participants of this study.

Posted

Number

pg/mL

ID	Title	Description
OG000	Trabectedin/DOXIL	30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Trabectedin/DOXIL	30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks			133	333	333	333
EG001	DOXIL	50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks			102	330	318	330

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00017 affected333 at risk EG0017 affected330 at risk
Bicytopenia	Blood and lymphatic system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Bone Marrow Failure	Blood and lymphatic system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0004 affected333 at risk EG0011 affected330 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00018 affected333 at risk EG0015 affected330 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00016 affected333 at risk EG0013 affected330 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00026 affected333 at risk EG0017 affected330 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0006 affected333 at risk EG0010 affected330 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00021 affected333 at risk EG0011 affected330 at risk
Cardiac Arrest	Cardiac disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0002 affected333 at risk EG0011 affected330 at risk
Electromechanical Dissociation	Cardiac disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Palpitations	Cardiac disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Adenomatous Polyposis Coli	Congenital, familial and genetic disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0011 affected330 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0006 affected333 at risk EG0019 affected330 at risk
Aphthous Stomatitis	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Ascites	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0006 affected333 at risk EG0017 affected330 at risk
Colonic Obstruction	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0012 affected330 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0013 affected330 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0006 affected333 at risk EG0013 affected330 at risk
Enterocutaneous Fistula	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Erosive Oesophagitis	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Gastrointestinal Disorder	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Gastrointestinal Obstruction	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0012 affected330 at risk
Ileus	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0014 affected330 at risk
Intestinal Fistula	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0011 affected330 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0007 affected333 at risk EG00111 affected330 at risk
Large Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Mechanical Ileus	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0012 affected330 at risk
Mouth Ulceration	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0012 affected330 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00014 affected333 at risk EG0018 affected330 at risk
Oesophageal Ulcer	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0012 affected330 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0007 affected333 at risk EG0013 affected330 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0012 affected330 at risk
Subileus	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0011 affected330 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00015 affected333 at risk EG0018 affected330 at risk
Adverse Drug Reaction	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0011 affected330 at risk
Asthenia	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0012 affected330 at risk
Catheter Related Complication	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0002 affected333 at risk EG0010 affected330 at risk
Catheter Site Phlebitis	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Chest Discomfort	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Chills	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Condition Aggravated	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Extravasation	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Fatigue	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0008 affected333 at risk EG0011 affected330 at risk
General Physical Health Deterioration	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0013 affected330 at risk
Hernia Obstructive	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Hernia Pain	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Mucosal Inflammation	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0013 affected330 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0002 affected333 at risk EG0011 affected330 at risk
Oedema Peripheral	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0010 affected330 at risk
Pain	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Pyrexia	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00010 affected333 at risk EG0013 affected330 at risk
Sudden Death	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Hepatitis	Hepatobiliary disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Hepatitis Cholestatic	Hepatobiliary disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Hepatitis Toxic	Hepatobiliary disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0002 affected333 at risk EG0010 affected330 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0012 affected330 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Hypersensitivity	Immune system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0002 affected333 at risk EG0013 affected330 at risk
Abscess	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Bacteraemia	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0010 affected330 at risk
Bacterial Sepsis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Bronchitis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Catheter Related Infection	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0011 affected330 at risk
Catheter Sepsis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Catheter Site Cellulitis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Catheter Site Infection	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0004 affected333 at risk EG0010 affected330 at risk
Cellulitis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0011 affected330 at risk
Central Line Infection	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Enterocolitis Infectious	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Erysipeloid	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Helicobacter Gastritis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Herpes Oesophagitis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Infection	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0012 affected330 at risk
Influenza	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Neutropenic Infection	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0010 affected330 at risk
Neutropenic Sepsis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0002 affected333 at risk EG0010 affected330 at risk
Oesophageal Candidiasis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Perineal Abscess	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Pharyngitis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Pneumonia	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0014 affected330 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Sepsis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0012 affected330 at risk
Septic Shock	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0002 affected333 at risk EG0012 affected330 at risk
Urinary Tract Infection Bacterial	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Urosepsis	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Device Dislocation	Injury, poisoning and procedural complications	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Medical Device Complication	Injury, poisoning and procedural complications	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Postoperative Ileus	Injury, poisoning and procedural complications	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Procedural Nausea	Injury, poisoning and procedural complications	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Procedural Vomiting	Injury, poisoning and procedural complications	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Thoracic Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG0005 affected333 at risk EG0010 affected330 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG0005 affected333 at risk EG0010 affected330 at risk
Blood Alkaline Phosphatase Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0010 affected330 at risk
Blood Creatine Phosphokinase Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Blood Creatinine Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Carbohydrate Antigen 125 Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Electrocardiogram Change	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Gamma-Glutamyltransferase Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Hepatic Enzyme Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Liver Function Test Abnormal	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Transaminases Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0016 affected330 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0007 affected333 at risk EG0014 affected330 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0011 affected330 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0011 affected330 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Metastases to Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Metastases to Soft Tissue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Oncologic Complication	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Paraneoplastic Syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Convulsion	Nervous system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Dizziness	Nervous system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Grand Mal Convulsion	Nervous system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Headache	Nervous system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Lethargy	Nervous system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0012 affected330 at risk
Loss of Consciousness	Nervous system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Syncope	Nervous system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0002 affected333 at risk EG0010 affected330 at risk
Syncope Vasovagal	Nervous system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Confusional State	Psychiatric disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0012 affected330 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Obstructive Uropathy	Renal and urinary disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0012 affected330 at risk
Renal Impairment	Renal and urinary disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Oedema Genital	Reproductive system and breast disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0013 affected330 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0013 affected330 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0013 affected330 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00013 affected333 at risk EG0016 affected330 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Melanosis	Skin and subcutaneous tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0014 affected330 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Arterial Insufficiency	Vascular disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Axillary Vein Thrombosis	Vascular disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0002 affected333 at risk EG0010 affected330 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0012 affected330 at risk
Haemorrhage	Vascular disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Hypotension	Vascular disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Jugular Vein Thrombosis	Vascular disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk
Subclavian Vein Thrombosis	Vascular disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0002 affected333 at risk EG0010 affected330 at risk
Thrombosis	Vascular disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0003 affected333 at risk EG0010 affected330 at risk
Vena Cava Thrombosis	Vascular disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0000 affected333 at risk EG0011 affected330 at risk
Venous Occlusion	Vascular disorders	MedDRA Version 11.1	Non-systematic Assessment	EG0001 affected333 at risk EG0010 affected330 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG000160 affected333 at risk EG00182 affected330 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG000164 affected333 at risk EG00191 affected330 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG000256 affected333 at risk EG001128 affected330 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG000115 affected333 at risk EG00127 affected330 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00018 affected333 at risk EG00123 affected330 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00070 affected333 at risk EG00176 affected330 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00019 affected333 at risk EG00125 affected330 at risk
Ascites	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00013 affected333 at risk EG00118 affected330 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG000109 affected333 at risk EG00192 affected330 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00084 affected333 at risk EG00163 affected330 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00043 affected333 at risk EG00135 affected330 at risk
Mouth Ulceration	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00011 affected333 at risk EG00121 affected330 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG000251 affected333 at risk EG001139 affected330 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00067 affected333 at risk EG001108 affected330 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG000188 affected333 at risk EG00197 affected330 at risk
Asthenia	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00056 affected333 at risk EG00138 affected330 at risk
Fatigue	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG000153 affected333 at risk EG001122 affected330 at risk
Mucosal Inflammation	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00042 affected333 at risk EG00164 affected330 at risk
Oedema Peripheral	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00030 affected333 at risk EG00128 affected330 at risk
Pain	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00018 affected333 at risk EG00112 affected330 at risk
Pyrexia	General disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00063 affected333 at risk EG00144 affected330 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00051 affected333 at risk EG00125 affected330 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 11.1	Non-systematic Assessment	EG00015 affected333 at risk EG00119 affected330 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG000185 affected333 at risk EG00133 affected330 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG000139 affected333 at risk EG00135 affected330 at risk
Blood Alkaline Phosphatase Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG00077 affected333 at risk EG00129 affected330 at risk
Blood Creatine Phosphokinase Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG00023 affected333 at risk EG00111 affected330 at risk
Blood Creatinine Increased	Investigations	MedDRA Version 11.1	Non-systematic Assessment	EG00021 affected333 at risk EG00120 affected330 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA Version 11.1	Non-systematic Assessment	EG000109 affected333 at risk EG00185 affected330 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00022 affected333 at risk EG00119 affected330 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00038 affected333 at risk EG00126 affected330 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00019 affected333 at risk EG00111 affected330 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00021 affected333 at risk EG00114 affected330 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00030 affected333 at risk EG00131 affected330 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00018 affected333 at risk EG00112 affected330 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00020 affected333 at risk EG00118 affected330 at risk
Dizziness	Nervous system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00033 affected333 at risk EG00122 affected330 at risk
Dysgeusia	Nervous system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00019 affected333 at risk EG00110 affected330 at risk
Headache	Nervous system disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00055 affected333 at risk EG00124 affected330 at risk
Anxiety	Psychiatric disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00023 affected333 at risk EG00111 affected330 at risk
Insomnia	Psychiatric disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00034 affected333 at risk EG00116 affected330 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00041 affected333 at risk EG00140 affected330 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00052 affected333 at risk EG00133 affected330 at risk
Pharyngolaryngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00017 affected333 at risk EG00124 affected330 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00042 affected333 at risk EG00148 affected330 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00018 affected333 at risk EG00110 affected330 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00018 affected333 at risk EG00119 affected330 at risk
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00086 affected333 at risk EG001179 affected330 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00011 affected333 at risk EG00120 affected330 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00036 affected333 at risk EG00159 affected330 at risk
Skin Hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA Version 11.1	Non-systematic Assessment	EG00021 affected333 at risk EG00124 affected330 at risk

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases
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

Ancestor Terms

ID	Term
D004149	Dioxoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D044005	Tetrahydroisoquinolines
D007546	Isoquinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama		United States

ID	Title	Description
BG000	DOXIL	50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
BG001	Trabectedin/DOXIL	30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
BG002	Total	Total of all reporting groups

ID	Term
D000077606	Trabectedin
C506643	liposomal doxorubicin
D003907	Dexamethasone