An Extension Study of NKTR-102 in Cancer Patients Previou... | NCT01457118

NCT01457118

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
NKTR-102	Experimental		Drug: NKTR-102 145 mg/m2 Drug: NKTR-102 120 mg/m2 Drug: NKTR-102 95 mg/m2 Drug: NKTR-102 50 mg/m2

Name	Type	Description	Arm Group Labels	Other Names
NKTR-102 145 mg/m2	Drug	A 90 minute IV infusion of 145 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.	NKTR-102

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of Exposure to NKTR-102	To provide access to NKTR-102 to subjects who previously received NKTR-102 in a clinical trial and were without signs of disease progression since receiving NKTR-102.	Screening, Every 21 day cycle of treatment and Quarterly Follow-up

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events	To evaluate the safety of continued exposure to NKTR-102.	Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Disease Status	To observe disease status and survival status in subjects receiving NKTR-102.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Study Director	Nektar Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigator Site - Los Angeles		Los Angeles	California	90033	United States
Investigator Site - San Francisco

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	145 mg/m2	NKTR-102: A 90 minute IV infusion of 145 mg/m2
FG001	120 mg/m2	NKTR-102: A 90 minute IV infusion of 120 mg/m2

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 14, 2016	Jun 14, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	145 mg/m2	NKTR-102: A 90 minute IV infusion of 145 mg/m2
BG001	120 mg/m2	NKTR-102: A 90 minute IV infusion of 120 mg/m2
BG002	95 mg/m2	NKTR-102: A 90 minute IV infusion of 95 mg/m2
BG003	50 mg/m2	NKTR-102: A 90 minute IV infusion of 50 mg/m2
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00020 BG0014 BG0021 BG0032 BG00427

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00020 ParticipantsBG0014 ParticipantsBG0021 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00020 ParticipantsBG0014 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00020 ParticipantsBG0014 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00020 ParticipantsBG0014 ParticipantsBG002

Primary Tumor Diagnosis

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00020 ParticipantsBG0014 ParticipantsBG002

Stage at Original NKTR-102 Study Enrollment

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00020 ParticipantsBG0014 ParticipantsBG002

Time Since Initial Diagnosis to Original NKTR-102 Study

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00020 ParticipantsBG0014 ParticipantsBG002

Treatment Duration in Original NKTR-102 Study

Mean

Standard Deviation

days

Title	Denominators	Categories
	ParticipantsBG00020 ParticipantsBG0014 ParticipantsBG002

Time Since Metastatic Diagnosis to Original NKTR-102 Study

The number analyzed differs from overall as not all patients reached metastatic diagnosis

Mean

Standard Deviation

days

Title	Denominators	Categories
	ParticipantsBG00018 ParticipantsBG0014 ParticipantsBG002

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

Length of Exposure to NKTR-102

To provide access to NKTR-102 to subjects who previously received NKTR-102 in a clinical trial and were without signs of disease progression since receiving NKTR-102.

Posted

Mean

Standard Deviation

days

Screening, Every 21 day cycle of treatment and Quarterly Follow-up

ID	Title	Description
OG000	145 mg/m2	NKTR-102: A 90 minute IV infusion of 145 mg/m2
OG001	120 mg/m2	NKTR-102: A 90 minute IV infusion of 120 mg/m2
OG002	95 mg/m2	NKTR-102: A 90 minute IV infusion of 95 mg/m2
OG003	50 mg/m2	NKTR-102: A 90 minute IV infusion of 50 mg/m2

Units	Counts
Participants	OG00020 OG0014 OG0021 OG003

Title

Denominators

Categories

Title	Measurements
	OG000139.0± 126.19 OG00133.0± 14.07 OG002126.0± NAThere is only one participant OG003

Secondary

Adverse Events

To evaluate the safety of continued exposure to NKTR-102.

Posted

Number

# of events

Screening, Every 21 day cycle of treatment and Quarterly Follow-up

ID	Title	Description
OG000	145 mg/m2	NKTR-102: A 90 minute IV infusion of 145 mg/m2
OG001	120 mg/m2	NKTR-102: A 90 minute IV infusion of 120 mg/m2
OG002	95 mg/m2	NKTR-102: A 90 minute IV infusion of 95 mg/m2
OG003	50 mg/m2	NKTR-102: A 90 minute IV infusion of 50 mg/m2

Units	Counts
Participants

Secondary

Disease Status

To observe disease status and survival status in subjects receiving NKTR-102.

Four participants including the one in Group 4 had to discontinue treatment prior to measuring this outcome

Posted

Count of Participants

Participants

Screening, Every 21 day cycle of treatment and Quarterly Follow-up

ID	Title	Description
OG000	145 mg/m2	NKTR-102: A 90 minute IV infusion of 145 mg/m2
OG001	120 mg/m2	NKTR-102: A 90 minute IV infusion of 120 mg/m2
OG002	95 mg/m2	NKTR-102: A 90 minute IV infusion of 95 mg/m2
OG003	50 mg/m2	NKTR-102: A 90 minute IV infusion of 50 mg/m2

Units	Counts

Secondary

Efficacy of NKTR-102

To evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.

Four participants including the one in Group 4 had to discontinue treatment prior to this outcome being measured.

Posted

Number

participants

Screening, Every 21 day cycle of treatment and Quarterly Follow-up

ID	Title	Description
OG000	145 mg/m2	NKTR-102: A 90 minute IV infusion of 145 mg/m2
OG001	120 mg/m2	NKTR-102: A 90 minute IV infusion of 120 mg/m2
OG002	95 mg/m2	NKTR-102: A 90 minute IV infusion of 95 mg/m2
OG003	50 mg/m2	NKTR-102: A 90 minute IV infusion of 50 mg/m2

Units	Counts

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	145 mg/m2	NKTR-102: A 90 minute IV infusion of 145 mg/m2	16	20	5	20	20	20
EG001	120 mg/m2	NKTR-102: A 90 minute IV infusion of 120 mg/m2	3	4	1	4	4	4
EG002	95 mg/m2	NKTR-102: A 90 minute IV infusion of 95 mg/m2	0	1	0	1	1	1
EG003	50 mg/m2	NKTR-102: A 90 minute IV infusion of 50 mg/m2	0	2	1	2	2	2

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG0030 affected2 at risk
Abdominal Infection	Infections and infestations	Systematic Assessment	EG0000 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0000 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
Herpex simplex encephalitis	Infections and infestations	Systematic Assessment	EG0000 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
Peritonitis bacterial	Infections and infestations	Systematic Assessment	EG0000 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
Appendix Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
Cancer Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
Renal Failure Acute	Renal and urinary disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
Hypotension	Vascular disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
Total Number of TESAEs	General disorders	Systematic Assessment	EG00010 events5 affected20 at risk EG0013 events1 affected4 at risk EG0020 events0 affected1 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
# of subjects with Anemia	Cardiac disorders	Systematic Assessment	EG0003 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG0030 affected2 at risk
# of subjects with Neutropenia	Immune system disorders	Systematic Assessment	EG0003 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Vision Blurred	Eye disorders	Systematic Assessment	EG0003 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Photophobia	General disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG00011 affected20 at risk EG0013 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Nausea	Gastrointestinal disorders	Systematic Assessment	EG0006 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0004 affected20 at risk EG0012 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Constipation	Gastrointestinal disorders	Systematic Assessment	EG0004 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Abdominal Pain	General disorders	Systematic Assessment	EG0002 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0002 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Upper Abdominal Pain	General disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Ascites	Hepatobiliary disorders	Systematic Assessment	EG0000 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Dry Mouth	General disorders	Systematic Assessment	EG0000 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Hypoesthesia Oral	Nervous system disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Mouth Ulceration	Infections and infestations	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Stomatitis	Infections and infestations	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Fatigue	General disorders	Systematic Assessment	EG0006 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Oedema Peripheral	Cardiac disorders	Systematic Assessment	EG0002 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Non-Cardiac Chest Pain	General disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Pyrexia	General disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Urinary Tract Infections	Infections and infestations	Systematic Assessment	EG0003 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Gastroenteritis	Infections and infestations	Systematic Assessment	EG0001 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Influenza	Infections and infestations	Systematic Assessment	EG0000 affected20 at risk EG0011 affected4 at risk EG0021 affected1 at risk EG003
# of subjects with Abdominal Infection	Infections and infestations	Systematic Assessment	EG0000 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Gingival Infection	Infections and infestations	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Herpes Simplex Encephalitis	Infections and infestations	Systematic Assessment	EG0000 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Weight Decreased	General disorders	Systematic Assessment	EG0005 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Neutrophil Count Decreased	Immune system disorders	Systematic Assessment	EG0001 affected20 at risk EG0011 affected4 at risk EG0021 affected1 at risk EG003
# of subjects with Aspartate Aminotransferase Increased	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with White Blood Cell count decreased	Immune system disorders	Systematic Assessment	EG0001 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Activated Partial Thromboplastin Time Prolonged	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Alanine Aminotransferase Increased	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Blood Bilirubin Increased	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Liver Function Test Abnormal	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Prothrombin Time Prolonged	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Decreased Appetite	General disorders	Systematic Assessment	EG0004 affected20 at risk EG0010 affected4 at risk EG0021 affected1 at risk EG003
# of subjects with Hypoalbuminemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Hypoglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Hypocalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Hypomagenesemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Hypophosphatemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Back Pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Flank Pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Muscular Weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Appendix Pain	General disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Cancer Pain	General disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Aphonia	General disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Dysgeusia	General disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Hypoesthesia	General disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Depressed Mood	Psychiatric disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Insomnia	Psychiatric disorders	Systematic Assessment	EG0000 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Proteinuria	Renal and urinary disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Acute Renal Failure	Renal and urinary disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Vaginal Hemorrhage	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Oropharyngeal Pain	General disorders	Systematic Assessment	EG0002 affected20 at risk EG0011 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Productive Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Pulmonary Embolism	Vascular disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Decubitus Ulcer	Infections and infestations	Systematic Assessment	EG0002 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Alopecia	General disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Hypotension	Cardiac disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Pelvic Venous Thrombosis	Vascular disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Peritonitis Bacterial	Infections and infestations	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Leukopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003
# of subjects with Blood Creatine Increased	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected20 at risk EG0010 affected4 at risk EG0020 affected1 at risk EG003

ID	Term
C581703	etirinotecan pegol