A Study of Tasisulam-sodium Versus Paclitaxel as Treatmen... | NCT01006252

ID	Type	Description	Link
H8K-MC-JZAO	Other Identifier	Eli Lilly and Company

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tasisulam-sodium	Experimental	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.	Drug: Tasisulam-sodium
Paclitaxel	Active Comparator	Paclitaxel 80 milligrams per square meter (mg/m^2) administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression	Drug: Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
Tasisulam-sodium	Drug	Administered intravenously on Day 1 of a 28-day cycle, until disease progression.	Tasisulam-sodium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS is duration from enrollment to death; OS censored for participants who were alive at last contact.	Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS is time from date of first dose to first observation of disease progression (PD); PD=20% increase in sum of the longest diameter of target lesions, or death from any cause.	Randomization to date of objectively determined PD, or death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 13.70 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a histologic and/or cytologic diagnosis of metastatic melanoma (Stage IV).
Have the presence of evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).
Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
Have progressed after 1 previous systemic treatment containing dacarbazine or temozolomide for metastatic melanoma.
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia).
Have a serum albumin level greater than or equal to 3.0 grams per deciliter (g/dL) or greater than or equal to 30 grams per liter (g/L).

Exclusion Criteria:

Have received greater than or equal to 2 previous chemotherapy-containing systemic treatment regimens for metastatic melanoma. An immunotherapy or antibody-based regimen (including biologic agents and vaccination-based treatments), or treatment with a targeted agent (for example, BRAF or c-Kit inhibitor is not counted as a prior treatment regimen for determining study eligibility, unless either was combined with a cytotoxic drug).
Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of study entry. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis. Participants with a history of a solitary CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) and not requiring steroids are eligible.
Are receiving warfarin.
Have primary ocular or mucosal melanoma.
Any previous treatment with paclitaxel or a paclitaxel-containing regimen for metastatic melanoma.
Have serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator).
Have previously completed or withdrawn from this study or any other study investigating tasisulam-sodium.
Have a known hypersensitivity to paclitaxel or Cremophor EL (polyoxyethylated castor oil).
Are pregnant or lactating.
Have received a recent (within 30 days before enrollment) or are receiving concurrent yellow fever vaccination.
Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
Are unable to withhold dosing of non-steroidal anti-inflammatory drugs (NSAIDs) or proton-pump inhibitors (PPIs) for at least 72 hours before and after treatment with tasisulam-sodium.

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.		Birmingham	Alabama	35243

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
FG001	Paclitaxel

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Title	Measurements
	BG00058.30± 13.20 BG00159.44± 13.43 BG00258.87± 13.31

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00065 BG00163 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0014 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00040 BG00150 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

Overall Survival (OS)

OS is duration from enrollment to death; OS censored for participants who were alive at last contact.

The intent-to-treat (ITT) analysis population included all participants randomized to treatment.

Posted

Median

95% Confidence Interval

months

Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months

ID	Title	Description
OG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
OG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.

Units	Counts
Participants	OG000168 OG001168

Title

Denominators

Categories

Title	Measurements
	OG0006.77(5.88 to 8.28) OG0019.36(6.90 to NA)The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

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		Stratified log rank		0.121	Statistical significance was assessed at an alpha level of 0.05.	Hazard Ratio (HR)	1.23				95							Superiority or Other

Secondary

Progression Free Survival (PFS)

PFS is time from date of first dose to first observation of disease progression (PD); PD=20% increase in sum of the longest diameter of target lesions, or death from any cause.

The intent-to-treat (ITT) analysis population included all participants randomized to treatment.

Posted

Median

95% Confidence Interval

months

Randomization to date of objectively determined PD, or death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 13.70 months

ID	Title	Description
OG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
OG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Units	Counts
Participants

Secondary

Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR)

Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions.

The intent-to-treat (ITT) analysis population included all participants randomized to treatment.

Posted

Number

95% Confidence Interval

percentage of participants

First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months

ID	Title	Description
OG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
OG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Units	Counts

Secondary

Duration of Response (DoR) for Participants Having an Objective Response of Partial Response (PR) or Complete Response (CR)

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions. Analysis was adjusted for Baseline Lactate Dehydrogenase (LDH); Disease Stage; Sex; Previous Single Agent Immunotherapy Treatment; Age Group. Due to limited number of responses for either treatment arm, DoR analysis was not performed.

Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis per study report.

Posted

First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months

ID	Title	Description
OG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
OG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Secondary

Percentage of Randomized Participants Having a Confirmed Best Overall Response of Partial Response (PR) or Complete Response (CR) Plus Participants With an Overall Response of Stable Disease (SD)

The intent-to-treat (ITT) analysis population included all participants randomized to treatment.

Posted

Number

95% Confidence Interval

percentage of participants

First date RECIST criteria met for CR, PR, or SD until first date of documented progressive disease (PD), or death from any cause (assessed every other cycle) up to 13.70 months

ID	Title	Description
OG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
OG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Secondary

Time to Deterioration in the Functional Assessment of Cancer Therapy-Melanoma Trial Outcome Index (FACT-M TOI) Score

FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. FACT-M TOI is the sum of FACT-M physical well-being, functional well-being, and melanoma subscales. Scores range from 0 to 120; Higher scores=better quality of life (QoL). FACT-M TOI score deterioration was defined as time from randomization to a minimally important difference in TOI score or death.

The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.

Posted

Median

95% Confidence Interval

months

Randomization to first date of deterioration in FACT-M TOI, or death from any cause (assessed every cycle and up to 30 days following treatment discontinuation) up to 13.21 months

ID	Title	Description
OG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
OG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Secondary

Change From Baseline at Cycle 2 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation

FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.

The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline at Cycle 2, up to 30 days following treatment discontinuation

ID	Title	Description
OG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
OG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Secondary

Change From Baseline at Cycle 3 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation

FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.

The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline at Cycle 3, up to 30 days following treatment discontinuation

ID	Title	Description
OG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle until disease progression.
OG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle until disease progression.

Secondary

Change From Baseline at Cycle 4 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation

FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.

The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline at Cycle 4, up to 30 days following treatment discontinuation

ID	Title	Description
OG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
OG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.

Secondary

Change From Baseline at Cycle 2 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation

EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe the status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.

The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline at Cycle 2, up to 30 days following treatment discontinuation

ID	Title	Description
OG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
OG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Secondary

Change From Baseline at Cycle 3 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation

EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.

The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline at Cycle 3, up to 30 days following treatment discontinuation

ID	Title	Description
OG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
OG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.

Secondary

Change From Baseline at Cycle 4 Baseline in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation

The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline at Cycle 4, up to 30 days after treatment discontinuation

ID	Title	Description
OG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
OG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression.

Secondary

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) During Cycle 1

The analysis population included all participants who received at least 1 dose of study drug for whom PK data were available. PK analysis were only performed on Tasisulam per protocol.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram per milliliter (µg/mL)

After drug infusion in Cycle 1 (5 samples drawn over the 28-day cycle)

ID	Title	Description
OG000	Tasisulam	Dose was adjusted based on participant laboratory parameters and lean body weight; administered intravenously every 28 days until disease progression, or other criteria for participant discontinuation were met.

Units	Counts
Participants	OG000

Secondary

Pharmacokinetics: Maximum Plasma Concentration (Cmax) During Cycle 2

The analysis population included all participants who received at least 2 doses of study drug for whom pharmacokinetic data were available. PK analysis were only performed on Tasisulam per protocol.

Posted

Geometric Mean

Geometric Coefficient of Variation

µg/mL

After drug infusion in Cycle 2 (2 samples drawn over the 28-day cycle)

ID	Title	Description
OG000	Tasisulam	Dose was adjusted based on participant laboratory parameters and lean body weight; administered intravenously every 28 days until disease progression, or other criteria for participant discontinuation were met.

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	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.			53	164	149	164
EG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression			44	161	146	161

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0005 events5 affected164 at risk EG0010 events0 affected161 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected164 at risk EG0011 events1 affected161 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Haemorrhagic diathesis	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0005 events5 affected164 at risk EG0010 events0 affected161 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0006 events6 affected164 at risk EG0012 events2 affected161 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG00019 events18 affected164 at risk EG0011 events1 affected161 at risk
Angina pectoris	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Arrhythmia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0011 events1 affected161 at risk
Atrioventricular block	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Bradycardia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0010 events0 affected161 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0013 events3 affected161 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Colitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected164 at risk EG0010 events0 affected161 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0010 events0 affected161 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0011 events1 affected161 at risk
Gastrointestinal fistula	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Ileus	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0011 events1 affected161 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0012 events2 affected161 at risk
Asthenia	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0010 events0 affected161 at risk
Chills	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Discomfort	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Fatigue	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0012 events2 affected161 at risk
Hyperthermia	General disorders	MedDRA 13.1	Systematic Assessment	EG0003 events2 affected164 at risk EG0010 events0 affected161 at risk
Non-cardiac chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0010 events0 affected161 at risk
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0013 events3 affected161 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Cellulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events1 affected164 at risk EG0011 events1 affected161 at risk
Device related infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Erysipelas	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0012 events2 affected161 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Herpes zoster	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0010 events0 affected161 at risk
Infected skin ulcer	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Lung infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0013 events3 affected161 at risk
Scrotal abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Sepsis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0011 events1 affected161 at risk
Septic shock	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected164 at risk EG0010 events0 affected161 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Wound infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Haemoglobin decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0011 events1 affected161 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0011 events1 affected161 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Malignant ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Brain oedema	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0010 events0 affected161 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Speech disorder	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Spinal cord compression	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Syncope	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Confusional state	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Panic attack	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Renal failure	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0011 events1 affected161 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Balanitis	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0012 events2 affected161 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0010 events0 affected161 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0014 events4 affected161 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected164 at risk EG0010 events0 affected161 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Circulatory collapse	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected161 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Hypotension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Lymphoedema	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected161 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG00017 events15 affected164 at risk EG00121 events19 affected161 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG00017 events13 affected164 at risk EG00127 events19 affected161 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG00028 events21 affected164 at risk EG0012 events2 affected161 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00013 events12 affected164 at risk EG00116 events14 affected161 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00010 events10 affected164 at risk EG0014 events4 affected161 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00016 events14 affected164 at risk EG00124 events23 affected161 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00039 events31 affected164 at risk EG00135 events29 affected161 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0006 events6 affected164 at risk EG00110 events9 affected161 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00033 events29 affected164 at risk EG00137 events36 affected161 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00017 events16 affected164 at risk EG00121 events21 affected161 at risk
Asthenia	General disorders	MedDRA 13.1	Systematic Assessment	EG00010 events10 affected164 at risk EG00121 events19 affected161 at risk
Fatigue	General disorders	MedDRA 13.1	Systematic Assessment	EG00052 events50 affected164 at risk EG00150 events47 affected161 at risk
Oedema peripheral	General disorders	MedDRA 13.1	Systematic Assessment	EG00014 events12 affected164 at risk EG00115 events15 affected161 at risk
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG00018 events17 affected164 at risk EG00115 events14 affected161 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG00022 events22 affected164 at risk EG00122 events20 affected161 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG00011 events9 affected164 at risk EG0016 events6 affected161 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0008 events7 affected164 at risk EG0019 events9 affected161 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0005 events5 affected164 at risk EG00114 events13 affected161 at risk
Dizziness	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0005 events5 affected164 at risk EG00111 events10 affected161 at risk
Dysgeusia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG00010 events10 affected164 at risk EG0015 events5 affected161 at risk
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG00029 events22 affected164 at risk EG00113 events12 affected161 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected164 at risk EG00113 events9 affected161 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0006 events5 affected164 at risk EG00112 events11 affected161 at risk
Insomnia	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0005 events5 affected164 at risk EG00110 events10 affected161 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG00016 events16 affected164 at risk EG00123 events21 affected161 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG00017 events14 affected164 at risk EG00120 events19 affected161 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0006 events5 affected164 at risk EG00110 events10 affected161 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG00015 events15 affected164 at risk EG00152 events51 affected161 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG00013 events11 affected164 at risk EG00111 events9 affected161 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG00029 events23 affected164 at risk EG00125 events23 affected161 at risk

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	Tasisulam-sodium	Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
BG001	Paclitaxel	Paclitaxel 80 mg/m^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
BG002	Total	Total of all reporting groups

ID	Term
C534068	N-((5-bromo-2-thienyl)sulfonyl)-2,4-dichlorobenzamide
D017239	Paclitaxel