Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizu... | NCT00609622

Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizu... | NCT00609622 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Treatment arm A - sunitinib plus mFOLFOX6	Drug: sunitinib Drug: mFOLFOX6
B	Active Comparator	Treatment arm B - bevacizumab plus mFOLFOX6	Drug: bevacizumab Drug: mFOLFOX6

Name	Type	Description	Arm Group Labels	Other Names
sunitinib	Drug	Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").	Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).	Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to Week 115)

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Fairhope	Alabama	36532	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33207247	Derived	Breen DM, Kim H, Bennett D, Calle RA, Collins S, Esquejo RM, He T, Joaquim S, Joyce A, Lambert M, Lin L, Pettersen B, Qiao S, Rossulek M, Weber G, Wu Z, Zhang BB, Birnbaum MJ. GDF-15 Neutralization Alleviates Platinum-Based Chemotherapy-Induced Emesis, Anorexia, and Weight Loss in Mice and Nonhuman Primates. Cell Metab. 2020 Dec 1;32(6):938-950.e6. doi: 10.1016/j.cmet.2020.10.023. Epub 2020 Nov 17.
26109878

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Sunitinib + mFOLFOX6	Sunitinib 37.5 milligram (mg) capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, lecovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg per square meter (mg/m^2) and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour intravenous (IV) infusion followed by an IV bolus of 5-fluorouracil (5-FU) 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG00014 subjects FG00110 subjects
Withdrawal by Subject		FG0004 subjects FG00120 subjects
Death		FG0001 subjects FG0014 subjects
Protocol Violation		FG0001 subjects FG0011 subjects
Objective progression or relapse		FG00047 subjects FG00141 subjects
Study terminated by sponsor		FG00016 subjects FG0013 subjects
Other		FG0007 subjects FG00114 subjects
Global deterioration of health status		FG0006 subjects FG0012 subjects

Arm/Group Information

ID	Title	Description
BG000	Sunitinib + mFOLFOX6	Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
BG001	Bevacizumab + mFOLFOX6	Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
BG002	Total	Total of all reporting groups

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
	BG00060.60± 9.26 BG00159.10± 10.81 BG00259.90± 10.06

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00035 BG00133 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)

Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").

The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.

Posted

Median

95% Confidence Interval

Weeks

Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)

ID	Title	Description
OG000	Sunitinib + mFOLFOX6	Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
OG001	Bevacizumab + mFOLFOX6	Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.

Units	Counts
Participants	OG00096 OG00195

Title

Denominators

Categories

Title	Measurements
	OG00040.50(39.50 to 44.20) OG00167.00(41.60 to 67.00)

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	P-value was calculated from a 1-sided, log-rank test stratified for Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), Baseline Lactate Dehydrogenase (LDH): greater than (>) 1.5 vs. less than or equal to (<=) 1.5 * upper limit of normal range (ULN), and Prior Adjuvant Treatment (yes vs. no).	Log Rank		0.9963		Hazard Ratio (HR)	2.705			2-Sided	95	1.272	5.751				No	Superiority or Other

Secondary

Overall Survival (OS)

Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.

Posted

Median

95% Confidence Interval

Weeks

Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to Week 115)

ID	Title	Description
OG000	Sunitinib + mFOLFOX6	Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
OG001	Bevacizumab + mFOLFOX6	Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.

Secondary

One Year Survival Probability

One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.

Data was not analyzed due to early study termination.

Posted

Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 1 year)

ID	Title	Description
OG000	Sunitinib + mFOLFOX6	Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
OG001	Bevacizumab + mFOLFOX6	Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.

Secondary

Two Year Survival Probability

Two year survival probability was defined as the probability of survival at two years after the first dose of study treatment.

Data was not analyzed due to early study termination.

Posted

Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 2 years)

ID	Title	Description
OG000	Sunitinib + mFOLFOX6	Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
OG001	Bevacizumab + mFOLFOX6	Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.

Secondary

Percentage of Participants With Objective Response (OR)

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115

ID	Title	Description
OG000	Sunitinib + mFOLFOX6	Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.

Secondary

Duration of Response (DR)

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Data was not analyzed due to early study termination.

Posted

Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115

ID	Title	Description
OG000	Sunitinib + mFOLFOX6	Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
OG001	Bevacizumab + mFOLFOX6	Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.

Secondary

Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score

FACT-C used for assessment of health-related quality of life (QoL) in participants with cancer. It consists of 36 items, summarized to 5 subscales:physical well-being (PWB) (7 items), functional well-being (FWB) (7 items), social/family well-being (SWB) (7 items); all 3 subscales range from 0 to 28, emotional well-being (EWB) (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.

FA set included participants randomized with study drug assignment, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. Here "n" signifies those participants evaluated for this measure at specific time point for each cohort respectively.

Posted

Mean

Standard Deviation

Units on a scale

Baseline [Day (D) 1 of Cycle (C) 1] then every 3 cycles thereafter and at the end of treatment (EOT) or withdrawal visit (up to Week 115)

ID	Title	Description
OG000	Sunitinib + mFOLFOX6	Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.

Secondary

Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score

FACT&GOG-Ntx has a 13-item, treatment-specific subscale for patients with neurotoxicity. It is the sum of the PWB (7 items), FWB (7 items), SWB (7 items) and EWB (6 items) subscales plus a 13 item neurotoxicity subscale. Subscale score ranges from 0 to 28 for PWB, FWB, SWB, 0 to 24 for EWB and 0 to 52 for neurotoxicity subscale. Total possible score range is 0 to 160. Higher scores indicates better QoL, fewer disease symptoms, and/or fewer side effects of treatment and lower scores indicate worse QoL and a greater impact of disease symptoms and/or side effects.

Posted

Mean

Standard Deviation

Units on a scale

Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks)

ID	Title	Description
OG000	Sunitinib + mFOLFOX6	Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.

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	Sunitinib + mFOLFOX6	Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.			36	96	96	96
EG001	Bevacizumab + mFOLFOX6	Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.			30	93	93	93

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v13.1	Non-systematic Assessment	EG0005 affected96 at risk EG0010 affected93 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA v13.1	Non-systematic Assessment	EG0002 affected96 at risk EG0010 affected93 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Coronary artery disease	Cardiac disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Prinzmetal angina	Cardiac disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Ocular icterus	Eye disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Constipation	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected93 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Gastritis	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0003 affected96 at risk EG0010 affected93 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Melaena	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Nausea	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Rectal ulcer	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0012 affected93 at risk
Vomiting	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0002 affected96 at risk EG0011 affected93 at risk
Adverse drug reaction	General disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Chest pain	General disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected93 at risk
Device dislocation	General disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Disease progression	General disorders	MedDRA v13.1	Non-systematic Assessment	EG0004 affected96 at risk EG0013 affected93 at risk
Medical device complication	General disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Pain	General disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0011 affected93 at risk
Pyrexia	General disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0012 affected93 at risk
Cholangitis	Hepatobiliary disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Cholestasis	Hepatobiliary disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Hepatitis	Hepatobiliary disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Anaphylactic reaction	Immune system disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Drug hypersensitivity	Immune system disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Abdominal infection	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Abdominal wall infection	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Abscess	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Bacteraemia	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0002 affected96 at risk EG0010 affected93 at risk
Bronchitis	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Cystitis	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Haemophilus bacteraemia	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Herpes zoster	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Infection	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Lung infection	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Pneumonia	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0002 affected96 at risk EG0012 affected93 at risk
Post procedural infection	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Septic shock	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Platelet count decreased	Investigations	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v13.1	Non-systematic Assessment	EG0005 affected96 at risk EG0012 affected93 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Dizziness	Nervous system disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Syncope	Nervous system disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Renal failure acute	Renal and urinary disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0002 affected96 at risk EG0012 affected93 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected93 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Hepatectomy	Surgical and medical procedures	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Deep vein thrombosis	Vascular disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0013 affected93 at risk
Haemorrhage	Vascular disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0010 affected93 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0012 affected93 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk
Thrombosis	Vascular disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0011 affected93 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v13.1	Non-systematic Assessment	EG00027 affected96 at risk EG00126 affected93 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v13.1	Non-systematic Assessment	EG00021 affected96 at risk EG00111 affected93 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v13.1	Non-systematic Assessment	EG00067 affected96 at risk EG00133 affected93 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v13.1	Non-systematic Assessment	EG00050 affected96 at risk EG00119 affected93 at risk
Lacrimation increased	Eye disorders	MedDRA v13.1	Non-systematic Assessment	EG0005 affected96 at risk EG0015 affected93 at risk
Vision blurred	Eye disorders	MedDRA v13.1	Non-systematic Assessment	EG0006 affected96 at risk EG0013 affected93 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0006 affected96 at risk EG0015 affected93 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG00020 affected96 at risk EG00121 affected93 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0001 affected96 at risk EG0015 affected93 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0006 affected96 at risk EG0017 affected93 at risk
Cheilitis	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0004 affected96 at risk EG0015 affected93 at risk
Constipation	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG00022 affected96 at risk EG00130 affected93 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG00066 affected96 at risk EG00149 affected93 at risk
Dry mouth	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG00011 affected96 at risk EG0015 affected93 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG00017 affected96 at risk EG0017 affected93 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0004 affected96 at risk EG0017 affected93 at risk
Flatulence	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0005 affected96 at risk EG0017 affected93 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG00011 affected96 at risk EG0017 affected93 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0015 affected93 at risk
Nausea	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG00062 affected96 at risk EG00157 affected93 at risk
Oral pain	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0006 affected96 at risk EG0015 affected93 at risk
Proctalgia	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0005 affected96 at risk EG0012 affected93 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0003 affected96 at risk EG0015 affected93 at risk
Stomatitis	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG00031 affected96 at risk EG00126 affected93 at risk
Vomiting	Gastrointestinal disorders	MedDRA v13.1	Non-systematic Assessment	EG00033 affected96 at risk EG00133 affected93 at risk
Asthenia	General disorders	MedDRA v13.1	Non-systematic Assessment	EG0008 affected96 at risk EG00111 affected93 at risk
Chest pain	General disorders	MedDRA v13.1	Non-systematic Assessment	EG0002 affected96 at risk EG00110 affected93 at risk
Chills	General disorders	MedDRA v13.1	Non-systematic Assessment	EG0002 affected96 at risk EG0016 affected93 at risk
Fatigue	General disorders	MedDRA v13.1	Non-systematic Assessment	EG00065 affected96 at risk EG00162 affected93 at risk
Mucosal inflammation	General disorders	MedDRA v13.1	Non-systematic Assessment	EG00012 affected96 at risk EG00121 affected93 at risk
Oedema peripheral	General disorders	MedDRA v13.1	Non-systematic Assessment	EG00011 affected96 at risk EG0015 affected93 at risk
Pain	General disorders	MedDRA v13.1	Non-systematic Assessment	EG0007 affected96 at risk EG0019 affected93 at risk
Pyrexia	General disorders	MedDRA v13.1	Non-systematic Assessment	EG00021 affected96 at risk EG00122 affected93 at risk
Hypersensitivity	Immune system disorders	MedDRA v13.1	Non-systematic Assessment	EG0002 affected96 at risk EG0015 affected93 at risk
Nasopharyngitis	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0004 affected96 at risk EG0019 affected93 at risk
Rhinitis	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0017 affected93 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG0004 affected96 at risk EG0016 affected93 at risk
Urinary tract infection	Infections and infestations	MedDRA v13.1	Non-systematic Assessment	EG00010 affected96 at risk EG0013 affected93 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA v13.1	Non-systematic Assessment	EG0005 affected96 at risk EG0011 affected93 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v13.1	Non-systematic Assessment	EG0005 affected96 at risk EG0015 affected93 at risk
Blood potassium decreased	Investigations	MedDRA v13.1	Non-systematic Assessment	EG0005 affected96 at risk EG0011 affected93 at risk
Haemoglobin decreased	Investigations	MedDRA v13.1	Non-systematic Assessment	EG0006 affected96 at risk EG0012 affected93 at risk
Neutrophil count decreased	Investigations	MedDRA v13.1	Non-systematic Assessment	EG00019 affected96 at risk EG0018 affected93 at risk
Platelet count decreased	Investigations	MedDRA v13.1	Non-systematic Assessment	EG00017 affected96 at risk EG0010 affected93 at risk
Weight decreased	Investigations	MedDRA v13.1	Non-systematic Assessment	EG00019 affected96 at risk EG00116 affected93 at risk
White blood cell count decreased	Investigations	MedDRA v13.1	Non-systematic Assessment	EG00013 affected96 at risk EG0015 affected93 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v13.1	Non-systematic Assessment	EG00032 affected96 at risk EG00136 affected93 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v13.1	Non-systematic Assessment	EG00011 affected96 at risk EG0016 affected93 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v13.1	Non-systematic Assessment	EG0003 affected96 at risk EG0016 affected93 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v13.1	Non-systematic Assessment	EG0005 affected96 at risk EG0012 affected93 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v13.1	Non-systematic Assessment	EG00018 affected96 at risk EG00110 affected93 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v13.1	Non-systematic Assessment	EG0005 affected96 at risk EG0012 affected93 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG0005 affected96 at risk EG0017 affected93 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG00013 affected96 at risk EG0018 affected93 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG0004 affected96 at risk EG0017 affected93 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG0006 affected96 at risk EG0016 affected93 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG0004 affected96 at risk EG0018 affected93 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG0008 affected96 at risk EG00110 affected93 at risk
Dizziness	Nervous system disorders	MedDRA v13.1	Non-systematic Assessment	EG00014 affected96 at risk EG00116 affected93 at risk
Dysgeusia	Nervous system disorders	MedDRA v13.1	Non-systematic Assessment	EG00031 affected96 at risk EG00121 affected93 at risk
Headache	Nervous system disorders	MedDRA v13.1	Non-systematic Assessment	EG00014 affected96 at risk EG00122 affected93 at risk
Hyperaesthesia	Nervous system disorders	MedDRA v13.1	Non-systematic Assessment	EG0007 affected96 at risk EG0018 affected93 at risk
Hypoaesthesia	Nervous system disorders	MedDRA v13.1	Non-systematic Assessment	EG0005 affected96 at risk EG0015 affected93 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v13.1	Non-systematic Assessment	EG00039 affected96 at risk EG00137 affected93 at risk
Paraesthesia	Nervous system disorders	MedDRA v13.1	Non-systematic Assessment	EG0006 affected96 at risk EG00114 affected93 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA v13.1	Non-systematic Assessment	EG00029 affected96 at risk EG00133 affected93 at risk
Polyneuropathy	Nervous system disorders	MedDRA v13.1	Non-systematic Assessment	EG0000 affected96 at risk EG0015 affected93 at risk
Anxiety	Psychiatric disorders	MedDRA v13.1	Non-systematic Assessment	EG0005 affected96 at risk EG00113 affected93 at risk
Depression	Psychiatric disorders	MedDRA v13.1	Non-systematic Assessment	EG0006 affected96 at risk EG00111 affected93 at risk
Insomnia	Psychiatric disorders	MedDRA v13.1	Non-systematic Assessment	EG00016 affected96 at risk EG00120 affected93 at risk
Proteinuria	Renal and urinary disorders	MedDRA v13.1	Non-systematic Assessment	EG0003 affected96 at risk EG0015 affected93 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG00015 affected96 at risk EG00116 affected93 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0002 affected96 at risk EG00111 affected93 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG00016 affected96 at risk EG00114 affected93 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0006 affected96 at risk EG0014 affected93 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG00022 affected96 at risk EG00130 affected93 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG00010 affected96 at risk EG0017 affected93 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0007 affected96 at risk EG0018 affected93 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v13.1	Non-systematic Assessment	EG0003 affected96 at risk EG0015 affected93 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG00017 affected96 at risk EG00124 affected93 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG0009 affected96 at risk EG0015 affected93 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG0003 affected96 at risk EG0015 affected93 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG00026 affected96 at risk EG00115 affected93 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG0007 affected96 at risk EG0019 affected93 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG00020 affected96 at risk EG00116 affected93 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG0009 affected96 at risk EG0015 affected93 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG0002 affected96 at risk EG0018 affected93 at risk
Yellow skin	Skin and subcutaneous tissue disorders	MedDRA v13.1	Non-systematic Assessment	EG0009 affected96 at risk EG0010 affected93 at risk
Hypertension	Vascular disorders	MedDRA v13.1	Non-systematic Assessment	EG00019 affected96 at risk EG00121 affected93 at risk
Hypotension	Vascular disorders	MedDRA v13.1	Non-systematic Assessment	EG0002 affected96 at risk EG0016 affected93 at risk

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

Title

Denominators

Categories

Title	Measurements
	OG00084.30(84.30 to NA)Upper limit of the confidence interval (C.I) was not reachable as data was not matured at the time of the analysis. OG001NA(NA to NA)Median OS could not be determined as data was not matured at the time of the analysis.

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	P-value was calculated from a 1-sided, log-rank test stratified for ECOG Performance Status (0 vs. 1), Baseline LDH: >1.5 vs. <=1.5 * ULN, and Prior Adjuvant Treatment (yes vs. no).	Log Rank		0.9289		Hazard Ratio (HR)	1.618			2-Sided	95	0.845	3.096				No	Superiority or Other

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		Chi-squared		0.5898		F-Distribution	3.956			2-Sided	95	-10.412	18.324				No	Superiority or Other

Title

Denominators

Categories

PWB Baseline (n= 93, 90)

Title	Measurements
	OG00023.21± 4.108 OG00123.29± 4.324

PWB Change at C4 D1 (n=80, 82)

Title	Measurements
	OG000-2.65± 4.132 OG001-1.24± 4.930

PWB Change at C7 D1 (n=59, 75)

Title	Measurements
	OG000-3.39± 5.532 OG001-1.94± 4.217

PWB Change at C10 D1 (n=45, 62)

Title	Measurements
	OG000-3.66± 4.732 OG001-1.85± 4.690

PWB Change at C13 D1 (n=34, 40)

Title	Measurements
	OG000-3.88± 4.969 OG001-2.24± 4.364

PWB Change at C16 D1 (n=25, 32)

Title	Measurements
	OG000-3.88± 4.850 OG001-2.83± 4.937

PWB Change at C19 D1 (n=13, 23)

Title	Measurements
	OG000-3.46± 4.977 OG001-1.49± 4.308

PWB Change at C22 D1 (n=6, 20)

Title	Measurements
	OG000-1.67± 4.885 OG001-2.08± 3.429

PWB Change at C25 D1 (n=1, 15)

Title	Measurements
	OG0007.00± NAStandard deviation was not estimable since only one participant was evaluable. OG001-1.90± 3.762

PWB Change at C28 D1 (n=1, 10)

Title	Measurements
	OG0004.0± NAStandard deviation was not estimable since only one participant was evaluable. OG001-1.6± 5.15

PWB Change at C31 D1 (n=1, 4)

Title	Measurements
	OG0003.0± NAStandard deviation was not estimable since only one participant was evaluable. OG001-2.8± 6.18

PWB Change at C34 D1 (n=1, 1)

Title	Measurements
	OG0006.0± NAStandard deviation was not estimable since only one participant was evaluable. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

PWB Change at C37 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

PWB Change at C40 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

PWB Change at C43 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

PWB Change at C46 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

PWB Change at C49 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

PWB Change at EOT (n=57, 43)

Title	Measurements
	OG000-4.16± 4.686 OG001-3.52± 6.222

SWB Baseline (n=93, 88)

Title	Measurements
	OG00023.42± 4.679 OG00123.16± 4.442

SWB Change at C4 D1 (n=80, 81)

Title	Measurements
	OG0000.03± 3.129 OG0010.31± 3.823

SWB Change at C7 D1 (n=59, 73)

Title	Measurements
	OG000-0.24± 3.941 OG0010.27± 3.931

SWB Change at C10 D1 (n=45, 60)

Title	Measurements
	OG000-0.89± 3.781 OG0010.05± 3.753

SWB Change at C13 D1 (n=34, 39)

Title	Measurements
	OG000-0.24± 2.486 OG001-1.33± 4.278

SWB Change at C16 D1 (n=25, 31)

Title	Measurements
	OG000-0.64± 3.369 OG001-1.24± 4.415

SWB Change at C19 D1 (n=13, 23)

Title	Measurements
	OG000-0.79± 2.024 OG001-1.47± 4.751

SWB Change at C22 D1 (n=6, 20)

Title	Measurements
	OG000-0.67± 2.065 OG001-1.18± 3.787

SWB Change at C25 D1 (n=1, 15)

Title	Measurements
	OG000-4.00± NAStandard deviation was not estimable since only one participant was evaluable. OG001-0.06± 4.191

SWB Change at C28 D1 (n=1, 10)

Title	Measurements
	OG000-3.50± NAStandard deviation was not estimable since only one participant was evaluable. OG001-0.65± 4.627

SWB Change at C31 D1 (n=1, 4)

Title	Measurements
	OG000-4.00± NAStandard deviation was not estimable since only one participant was evaluable. OG0013.58± 3.233

SWB Change at C34 D1 (n=1, 1)

Title	Measurements
	OG000-3.50± NAStandard deviation was not estimable since only one participant was evaluable. OG0011.00± NAStandard deviation was not estimable since only one participant was evaluable.

SWB Change at C37 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0011.0± NAStandard deviation was not estimable since only one participant was evaluable.

SWB Change at C 40 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

SWB Change at C43 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

SWB Change at C46 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

SWB Change at C49 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

SWB Change at EOT (n=57, 43)

Title	Measurements
	OG000-0.35± 3.501 OG001-0.63± 2.902

EWB Baseline (n=93, 90)

Title	Measurements
	OG00016.74± 4.342 OG00117.30± 3.995

EWB Change at C4 D1 (n=80, 82)

Title	Measurements
	OG0000.95± 3.505 OG0011.40± 4.108

EWB Change at C7 D1 (n=59, 75)

Title	Measurements
	OG0001.65± 3.108 OG0011.71± 4.036

EWB Change at C10 D1 (n=45, 62)

Title	Measurements
	OG0001.40± 4.014 OG0011.65± 4.121

EWB Change at C13 D1 (n=34, 40)

Title	Measurements
	OG0001.3± 4.45 OG0011.4± 4.30

EWB Change at C16 D1 (n=25, 32)

Title	Measurements
	OG0000.84± 3.934 OG0010.96± 4.511

EWB Change at C19 D1 (n=13, 23)

Title	Measurements
	OG0001.2± 2.92 OG0011.8± 4.56

EWB Change at C22 D1 (n=6, 20)

Title	Measurements
	OG0000.2± 3.66 OG0011.1± 3.39

EWB Change at C25 D1 (n=1, 15)

Title	Measurements
	OG0004.0± NAStandard deviation was not estimable since only one participant was evaluable. OG001-0.3± 5.32

EWB Change at C28 D1 (n=1, 10)

Title	Measurements
	OG0004.0± NAStandard deviation was not estimable since only one participant was evaluable. OG0010.1± 3.45

EWB Change at C31 D1 (n=1, 4)

Title	Measurements
	OG0002.0± NAStandard deviation was not estimable since only one participant was evaluable. OG0012.3± 4.50

EWB Change at C34 D1 (n=1, 1)

Title	Measurements
	OG0004.0± NAStandard deviation was not estimable since only one participant was evaluable. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

EWB Change at C37 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

EWB Change at C40 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0011.0± NAStandard deviation was not estimable since only one participant was evaluable.

EWB Change at C43 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0011.0± NAStandard deviation was not estimable since only one participant was evaluable.

EWB Change at C46 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0011.0± NAStandard deviation was not estimable since only one participant was evaluable.

EWB Change at C49 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0011.0± NAStandard deviation was not estimable since only one participant was evaluable.

EWB Change at EOT (n=57, 43)

Title	Measurements
	OG0000.35± 4.805 OG0010.77± 4.942

FWB Baseline (n=93, 89)

Title	Measurements
	OG00017.88± 5.818 OG00117.29± 6.328

FWB Change at C4 D1 (n=80, 81)

Title	Measurements
	OG000-0.78± 5.007 OG0011.56± 5.536

FWB Change at C7 D1 (n=59, 74)

Title	Measurements
	OG000-0.02± 5.425 OG0011.02± 5.493

FWB Change at C10 D1 (n=45, 61)

Title	Measurements
	OG000-0.35± 4.471 OG0010.74± 5.884

FWB Change at C13 D1 (n=34, 40)

Title	Measurements
	OG000-0.4± 5.02 OG0010.8± 5.88

FWB Change at C16 D1 (n=24, 31)

Title	Measurements
	OG000-0.7± 3.65 OG001-0.7± 4.95

FWB Change at C19 D1 (n=13, 22)

Title	Measurements
	OG000-0.3± 3.88 OG0010.1± 6.11

FWB Change at C22 D1 (n=6, 19)

Title	Measurements
	OG0000.7± 6.35 OG001-0.8± 4.72

FWB Change at C25 D1 (n=1, 14)

Title	Measurements
	OG00012.0± NAStandard deviation was not estimable since only one participant was evaluable. OG001-1.0± 4.40

FWB Change at C28 D1 (n=1, 9)

Title	Measurements
	OG00013.0± NAStandard deviation was not estimable since only one participant was evaluable. OG001-0.8± 4.74

FWB Change at C31 D1 (n=1, 3)

Title	Measurements
	OG0006.0± NAStandard deviation was not estimable since only one participant was evaluable. OG0011.0± 3.61

FWB Change at C34 D1 (n=1, 1)

Title	Measurements
	OG00012.0± NAStandard deviation was not estimable since only one participant was evaluable. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

FWB Change at C37 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

FWB Change at C40 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG001-3.0± NAStandard deviation was not estimable since only one participant was evaluable.

FWB Change at C43 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG001-3.0± NAStandard deviation was not estimable since only one participant was evaluable.

FWB Change at C46 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG001-3.0± NAStandard deviation was not estimable since only one participant was evaluable.

FWB Change at C49 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG001-3.0± NAStandard deviation was not estimable since only one participant was evaluable.

FWB Change at EOT (n=56, 43)

Title	Measurements
	OG0001.62± 5.394 OG0010.14± 6.075

CCS Baseline (n=93, 90)

Title	Measurements
	OG00020.93± 4.733 OG00121.26± 5.064

CCS Change at C4 D1 (n=78, 82)

Title	Measurements
	OG000-1.49± 4.228 OG001-0.13± 4.485

CCS Change at C7 D1 (n=60, 75)

Title	Measurements
	OG000-1.00± 5.193 OG001-0.26± 4.726

CCS Change at C10 D1 (n=45, 62)

Title	Measurements
	OG000-1.03± 4.859 OG001-0.16± 5.474

CCS Change at C13 D1 (n=34, 40)

Title	Measurements
	OG000-1.33± 5.224 OG001-0.20± 5.105

CCS Change at C16 D1 (n=25, 32)

Title	Measurements
	OG000-1.32± 4.425 OG001-1.25± 5.086

CCS Change at C19 D1 (n=13, 23)

Title	Measurements
	OG000-2.13± 4.732 OG001-0.36± 4.754

CCS Change at C22 D1 (n=6, 20)

Title	Measurements
	OG000-0.92± 5.219 OG0010.15± 3.815

CCS Change at C25 D1 (n=1, 15)

Title	Measurements
	OG0001.0± NAStandard deviation was not estimable since only one participant was evaluable. OG0011.3± 5.55

CCS Change at C28 D1 (n=1, 10)

Title	Measurements
	OG000-2.0± NAStandard deviation was not estimable since only one participant was evaluable. OG0010.4± 5.46

CCS Change at C31 D1 (n=1, 4)

Title	Measurements
	OG000-2.0± NAStandard deviation was not estimable since only one participant was evaluable. OG0011.8± 4.35

CCS Change at C34 D1 (n=1, 1)

Title	Measurements
	OG000-1.0± NAStandard deviation was not estimable since only one participant was evaluable. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

CCS Change at C37 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

CCS Change at C40 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG001-1.0± NAStandard deviation was not estimable since only one participant was evaluable.

CCS Change at C43 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG001-1.0± NAStandard deviation was not estimable since only one participant was evaluable.

CCS Change at C46 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

CCS Change at C49 D1 (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable since only one participant was evaluable.

CCS Change at EOT (n=55, 43)

Title	Measurements
	OG000-1.06± 4.942 OG001-0.48± 5.679

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Differences in PWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.0515	Mean Difference (Net)	-1.40	2-Sided	95	-2.82	0.01	No	Superiority or Other
OG000 OG001	Differences in PWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.0876	Mean Difference (Net)	-1.45	2-Sided	95	-3.11	0.22	No	Superiority or Other
OG000 OG001	Differences in PWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.0522	Mean Difference (Net)	-1.81	2-Sided	95	-3.64	0.02	No	Superiority or Other
OG000 OG001	Differences in PWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.1339	Mean Difference (Net)	-1.64	2-Sided	95	-3.81	0.52	No	Superiority or Other
OG000 OG001	Differences in PWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.4233	Mean Difference (Net)	-1.05	2-Sided	95	-3.68	1.57	No	Superiority or Other
OG000 OG001	Differences in PWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.2211	Mean Difference (Net)	-1.97	2-Sided	95	-5.18	1.24	No	Superiority or Other
OG000 OG001	Differences in PWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.8184	Mean Difference (Net)	0.41	2-Sided	95	-3.22	4.04	No	Superiority or Other
OG000 OG001	Differences in PWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.0380	Mean Difference (Net)	8.90	2-Sided	95	0.57	17.23	No	Superiority or Other
OG000 OG001	Differences in PWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.3266	Mean Difference (Net)	5.60	2-Sided	95	-6.61	17.81	No	Superiority or Other
OG000 OG001	Differences in PWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.4667	Mean Difference (Net)	5.75	2-Sided	95	-16.26	27.76	No	Superiority or Other
OG000 OG001	Differences in PWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	<0.0001	Mean Difference (Net)	0	2-Sided	95	0	0	No	Superiority or Other
OG000 OG001	Differences in PWB between treatment arms (EOT) was analyzed from a two-sample t-test.	t-test, 2 sided	0.5587	Mean Difference (Net)	-0.64	2-Sided	95	-2.80	1.52	No	Superiority or Other
OG000 OG001	Differences in SWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.6122	Mean Difference (Net)	-0.28	2-Sided	95	-1.37	0.81	No	Superiority or Other
OG000 OG001	Differences in SWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.4642	Mean Difference (Net)	-0.51	2-Sided	95	-1.87	0.86	No	Superiority or Other
OG000 OG001	Differences in SWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.2105	Mean Difference (Net)	-0.94	2-Sided	95	-2.41	0.54	No	Superiority or Other
OG000 OG001	Differences in SWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.1950	Mean Difference (Net)	1.09	2-Sided	95	-0.57	2.76	No	Superiority or Other
OG000 OG001	Differences in SWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.5779	Mean Difference (Net)	0.60	2-Sided	95	-1.55	2.75	No	Superiority or Other
OG000 OG001	Differences in SWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.6314	Mean Difference (Net)	0.67	2-Sided	95	-2.15	3.50	No	Superiority or Other
OG000 OG001	Differences in SWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.7554	Mean Difference (Net)	0.51	2-Sided	95	-2.85	3.87	No	Superiority or Other
OG000 OG001	Differences in SWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.3781	Mean Difference (Net)	-3.94	2-Sided	95	-13.22	5.34	No	Superiority or Other
OG000 OG001	Differences in SWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.5715	Mean Difference (Net)	-2.85	2-Sided	95	-13.83	8.13	No	Superiority or Other
OG000 OG001	Differences in SWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.1271	Mean Difference (Net)	-7.58	2-Sided	95	-19.08	3.93	No	Superiority or Other
OG000 OG001	Differences in SWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	<0.0001	Mean Difference (Net)	0	2-Sided	95	0	0	No	Superiority or Other
OG000 OG001	Differences in SWB between treatment arms (EOT) was analyzed from a two-sample t-test.	t-test, 2 sided	0.6785	Mean Difference (Net)	0.27	2-Sided	95	-1.03	1.58	No	Superiority or Other
OG000 OG001	Differences in EWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.4623	Mean Difference (Net)	-0.44	2-Sided	95	-1.63	0.74	No	Superiority or Other
OG000 OG001	Differences in EWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.9302	Mean Difference (Net)	-0.06	2-Sided	95	-1.31	1.20	No	Superiority or Other
OG000 OG001	Differences in EWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.7502	Mean Difference (Net)	-0.25	2-Sided	95	-1.84	1.33	No	Superiority or Other
OG000 OG001	Differences in EWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.9335	Mean Difference (Net)	-0.09	2-Sided	95	-2.12	1.95	No	Superiority or Other
OG000 OG001	Differences in EWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.9191	Mean Difference (Net)	-0.12	2-Sided	95	-2.40	2.17	No	Superiority or Other
OG000 OG001	Differences in EWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.6750	Mean Difference (Net)	-0.60	2-Sided	95	-3.46	2.27	No	Superiority or Other
OG000 OG001	Differences in EWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.5874	Mean Difference (Net)	-0.88	2-Sided	95	-4.20	2.43	No	Superiority or Other
OG000 OG001	Differences in EWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.4507	Mean Difference (Net)	4.27	2-Sided	95	-7.53	16.06	No	Superiority or Other
OG000 OG001	Differences in EWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.3087	Mean Difference (Net)	3.90	2-Sided	95	-4.28	12.08	No	Superiority or Other
OG000 OG001	Differences in EWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.9635	Mean Difference (Net)	-0.25	2-Sided	95	-16.26	15.76	No	Superiority or Other
OG000 OG001	Differences in EWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	<0.0001	Mean Difference (Net)	0	2-Sided	95	0	0	No	Superiority or Other
OG000 OG001	Differences in EWB between treatment arms (EOT) was analyzed from a two-sample t-test.	t-test, 2 sided	0.6699	Mean Difference (Net)	-0.42	2-Sided	95	-2.37	1.53	No	Superiority or Other
OG000 OG001	Differences in FWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.0055	Mean Difference (Net)	-2.34	2-Sided	95	-3.98	-0.70	No	Superiority or Other
OG000 OG001	Differences in FWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.2793	Mean Difference (Net)	-1.04	2-Sided	95	-2.92	0.85	No	Superiority or Other
OG000 OG001	Differences in FWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.2999	Mean Difference (Net)	-1.09	2-Sided	95	-3.17	0.99	No	Superiority or Other
OG000 OG001	Differences in FWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.3270	Mean Difference (Net)	-1.27	2-Sided	95	-3.82	1.29	No	Superiority or Other
OG000 OG001	Differences in FWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.9779	Mean Difference (Net)	0.03	2-Sided	95	-2.39	2.45	No	Superiority or Other
OG000 OG001	Differences in FWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.8344	Mean Difference (Net)	-0.40	2-Sided	95	-4.25	3.45	No	Superiority or Other
OG000 OG001	Differences in FWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.5494	Mean Difference (Net)	1.46	2-Sided	95	-3.50	6.41	No	Superiority or Other
OG000 OG001	Differences in FWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.0136	Mean Difference (Net)	13.00	2-Sided	95	3.15	22.85	No	Superiority or Other
OG000 OG001	Differences in FWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.0247	Mean Difference (Net)	13.78	2-Sided	95	2.26	25.29	No	Superiority or Other
OG000 OG001	Differences in FWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.3527	Mean Difference (Net)	5.00	2-Sided	95	-12.91	22.91	No	Superiority or Other
OG000 OG001	Differences in FWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	<0.0001	Mean Difference (Net)	0	2-Sided	95	0	0	No	Superiority or Other
OG000 OG001	Differences in FWB between treatment arms (EOT) was analyzed from a two-sample t-test.	t-test, 2 sided	0.1309	Mean Difference (Net)	-1.76	2-Sided	95	-4.05	0.53	No	Superiority or Other
OG000 OG001	Differences in CCS between treatment arms (C4 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.0510	Mean Difference (Net)	-1.36	2-Sided	95	-2.72	0.01	No	Superiority or Other
OG000 OG001	Differences in CCS between treatment arms (C7 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.3858	Mean Difference (Final Values)	-0.74	2-Sided	95	-2.44	0.95	No	Superiority or Other
OG000 OG001	Differences in CCS between treatment arms (C10 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.3943	Mean Difference (Net)	-0.88	2-Sided	95	-2.90	1.15	No	Superiority or Other
OG000 OG001	Differences in CCS between treatment arms (C13 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.3499	Mean Difference (Net)	-1.13	2-Sided	95	-3.53	1.27	No	Superiority or Other
OG000 OG001	Differences in CCS between treatment arms (C16 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.9567	Mean Difference (Net)	-0.07	2-Sided	95	-2.64	2.50	No	Superiority or Other
OG000 OG001	Differences in CCS between treatment arms (C19 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.2901	Mean Difference (Net)	-1.77	2-Sided	95	-5.12	1.58	No	Superiority or Other
OG000 OG001	Differences in CCS between treatment arms (C22 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.5857	Mean Difference (Net)	-1.07	2-Sided	95	-5.05	2.92	No	Superiority or Other
OG000 OG001	Differences in CCS between treatment arms (C25 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.9635	Mean Difference (Net)	-0.27	2-Sided	95	-12.56	12.02	No	Superiority or Other
OG000 OG001	Differences in CCS between treatment arms (C28 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.6850	Mean Difference (Net)	-2.40	2-Sided	95	-15.36	10.56	No	Superiority or Other
OG000 OG001	Differences in CCS between treatment arms (C31 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.4968	Mean Difference (Net)	-3.75	2-Sided	95	-19.23	11.73	No	Superiority or Other
OG000 OG001	Differences in CCS between treatment arms (C34 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	<0.0001	Mean Difference (Net)	0	2-Sided	95	0	0	No	Superiority or Other
OG000 OG001	Differences in CCS between treatment arms (EOT) was analyzed from a two-sample t-test.	t-test, 2 sided	0.5891	Mean Difference (Net)	-0.58	2-Sided	95	-2.71	1.55	No	Superiority or Other

Title

Denominators

Categories

Baseline (Neurotoxicity) (n=90, 93)

Title	Measurements
	OG00044.04± 4.853 OG00144.41± 4.808

Change at C4 D1 (Neurotoxicity) (n=75, 80)

Title	Measurements
	OG000-4.73± 6.270 OG001-4.10± 5.514

Change at C7 D1 (Neurotoxicity) (n=60, 74)

Title	Measurements
	OG000-6.20± 7.504 OG001-5.76± 5.560

Change at C10 D1 (Neurotoxicity) (n=45, 61)

Title	Measurements
	OG000-10.21± 8.800 OG001-7.45± 7.231

Change at C13 D1 (Neurotoxicity) (n=34, 40)

Title	Measurements
	OG000-13.96± 9.494 OG001-12.73± 9.420

Change at C16 D1 (Neurotoxicity) (n=24, 31)

Title	Measurements
	OG000-15.58± 8.356 OG001-14.55± 10.977

Change at C19 D1 (Neurotoxicity) (n=13, 23)

Title	Measurements
	OG000-12.4± 8.58 OG001-16.6± 9.71

Change at C22 D1 (Neurotoxicity) (n=5, 20)

Title	Measurements
	OG000-5.60± 6.914 OG001-13.87± 8.122

Change at C25 D1 (Neurotoxicity) (n=1, 14)

Title	Measurements
	OG000-13.0± NAStandard deviation was not estimable as only one participant was evaluable. OG001-16.9± 9.09

Change at C28 D1 (Neurotoxicity) (n=1, 10)

Title	Measurements
	OG000-13.0± NAStandard deviation was not estimable as only one participant was evaluable. OG001-14.0± 8.03

Change at C31 D1 (Neurotoxicity) (n=1, 4)

Title	Measurements
	OG000-12.0± NAStandard deviation was not estimable as only one participant was evaluable. OG001-13.8± 4.11

Change at C34 D1 (Neurotoxicity) (n=1, 1)

Title	Measurements
	OG000-12.0± NAStandard deviation was not estimable as only one participant was evaluable. OG001-9.0± NAStandard deviation was not estimable as only one participant was evaluable.

Change at C37 D1 (Neurotoxicity) (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG001-9.0± NAStandard deviation was not estimable as only one participant was evaluable.

Change at C40 D1 (Neurotoxicity) (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG001-10.0± NAStandard deviation was not estimable as only one participant was evaluable.

Change at C43 D1 (Neurotoxicity) (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG001-10.0± NAStandard deviation was not estimable as only one participant was evaluable.

Change at C46 D1 (Neurotoxicity) (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG001-8.0± NAStandard deviation was not estimable as only one participant was evaluable.

Change at C49 D1 (Neurotoxicity) (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG001-8.0± NAStandard deviation was not estimable as only one participant was evaluable.

Change at EOT (Neurotoxicity) (n=56, 43)

Title	Measurements
	OG000-10.71± 9.561 OG001-9.97± 8.632

Baseline (Item 13) (n=90, 93)

Title	Measurements
	OG0003.8± 0.55 OG0013.9± 0.42

Change at C4 D1 (Item 13) (n=75, 79)

Title	Measurements
	OG000-0.2± 0.52 OG001-0.2± 0.65

Change at C7 D1 (Item 13) (n=60, 74)

Title	Measurements
	OG000-0.3± 0.68 OG001-0.2± 0.56

Change at C10 D1 (Item 13) (n=45, 61)

Title	Measurements
	OG000-0.4± 0.87 OG001-0.2± 0.79

Change at C13 D1 (Item 13) (n=34, 40)

Title	Measurements
	OG000-0.4± 0.86 OG001-0.2± 0.68

Change at C16 D1 (Item 13) (n=24, 31)

Title	Measurements
	OG000-0.6± 1.03 OG001-0.6± 0.89

Change at C19 D1 (Item 13) (n=13, 23)

Title	Measurements
	OG000-0.3± 0.48 OG001-0.7± 1.19

Change at C22 D1 (Item 13) (n=5, 20)

Title	Measurements
	OG000-0.4± 0.55 OG001-0.4± 0.88

Change at C25 D1 (Item 13) (n=1, 14)

Title	Measurements
	OG0000.0± NAStandard deviation was not estimable as only one participant was evaluable. OG001-0.6± 0.94

Change at C28 D1 (Item 13) (n=1, 10)

Title	Measurements
	OG000-1.0± NAStandard deviation was not estimable as only one participant was evaluable. OG001-0.6± 1.07

Change at C31 D1 (Item 13) (n=1, 4)

Title	Measurements
	OG0000.0± NAStandard deviation was not estimable as only one participant was evaluable. OG001-1.3± 0.96

Change at C34 D1 (Item 13) (n=1, 1)

Title	Measurements
	OG000-1.0± NAStandard deviation was not estimable as only one participant was evaluable. OG001-1.0± NAStandard deviation was not estimable as only one participant was evaluable.

Change at C37 D1 (Item 13) (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG001-1.0± NAStandard deviation was not estimable as only one participant was evaluable.

Change at C40 D1 (Item 13) (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable as only one participant was evaluable.

Change at C43 D1 (Item 13) (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable as only one participant was evaluable.

Change at C46 D1 (Item 13) (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable as only one participant was evaluable.

Change at C49 D1 (Item 13) (n=0, 1)

Title	Measurements
	OG000NA± NAData was not analyzed due to early study termination. OG0010.0± NAStandard deviation was not estimable as only one participant was evaluable.

Change at EOT (Item 13) (n=56, 43)

Title	Measurements
	OG000-0.4± 0.85 OG001-0.3± 0.78

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Differences in neurotoxicity between treatment arms (C4 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.5081	Mean Difference (Net)	-0.63	2-Sided	95	-2.50	1.24	No	Superiority or Other
OG000 OG001	Differences in neurotoxicity between treatment arms (C7 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.6977	Mean Difference (Net)	-0.44	2-Sided	95	-2.67	1.79	No	Superiority or Other
OG000 OG001	Differences in neurotoxicity between treatment arms (C10 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.0797	Mean Difference (Net)	-2.76	2-Sided	95	-5.85	0.33	No	Superiority or Other
OG000 OG001	Differences in neurotoxicity between treatment arms (C13 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.5808	Mean Difference (Net)	-1.22	2-Sided	95	-5.62	3.17	No	Superiority or Other
OG000 OG001	Differences in neurotoxicity between treatment arms (C16 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.7046	Mean Difference (Net)	-1.03	2-Sided	95	-6.44	4.38	No	Superiority or Other
OG000 OG001	Differences in neurotoxicity between treatment arms (C19 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.2052	Mean Difference (Net)	4.18	2-Sided	95	-2.40	10.76	No	Superiority or Other
OG000 OG001	Differences in neurotoxicity between treatment arms (C22 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.0483	Mean Difference (Net)	8.27	2-Sided	95	0.07	16.46	No	Superiority or Other
OG000 OG001	Differences in neurotoxicity between treatment arms (C25 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.6832	Mean Difference (Net)	3.93	2-Sided	95	-16.41	24.26	No	Superiority or Other
OG000 OG001	Differences in neurotoxicity between treatment arms (C28 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.9081	Mean Difference (Net)	1.00	2-Sided	95	-18.05	20.05	No	Superiority or Other
OG000 OG001	Differences in neurotoxicity between treatment arms (C31 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.7289	Mean Difference (Net)	1.75	2-Sided	95	-12.88	16.38	No	Superiority or Other
OG000 OG001	Differences in neurotoxicity between treatment arms (C34 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	<0.0001	Mean Difference (Net)	0	2-Sided	95	0	0	No	Superiority or Other
OG000 OG001	Differences in neurotoxicity between treatment arms (EOT) was analyzed from a two-sample t-test.	t-test, 2 sided	0.6921	Mean Difference (Net)	-0.74	2-Sided	95	-4.43	2.95	No	Superiority or Other
OG000 OG001	Differences in item 13 between treatment arms (C4 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.9788	Mean Difference (Net)	0.00	2-Sided	95	-0.19	0.19	No	Superiority or Other
OG000 OG001	Differences in item 13 between treatment arms (C7 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.2747	Mean Difference (Net)	-0.12	2-Sided	95	-0.33	0.09	No	Superiority or Other
OG000 OG001	Differences in item 13 between treatment arms (C10 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.2776	Mean Difference (Net)	-0.18	2-Sided	95	-0.50	0.14	No	Superiority or Other
OG000 OG001	Differences in item 13 between treatment arms (C13 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.1403	Mean Difference (Net)	-0.27	2-Sided	95	-0.62	0.09	No	Superiority or Other
OG000 OG001	Differences in item 13 between treatment arms (C16 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.9151	Mean Difference (Net)	-0.03	2-Sided	95	-0.55	0.50	No	Superiority or Other
OG000 OG001	Differences in item 13 between treatment arms (C19 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.3277	Mean Difference (Net)	0.34	2-Sided	95	-0.36	1.05	No	Superiority or Other
OG000 OG001	Differences in item 13 between treatment arms (C22 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	1.0000	Mean Difference (Net)	-0.00	2-Sided	95	-0.86	0.86	No	Superiority or Other
OG000 OG001	Differences in item 13 between treatment arms (C25 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.5661	Mean Difference (Net)	0.57	2-Sided	95	-1.53	2.67	No	Superiority or Other
OG000 OG001	Differences in item 13 between treatment arms (C28 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.7309	Mean Difference (Net)	-0.40	2-Sided	95	-2.95	2.15	No	Superiority or Other
OG000 OG001	Differences in item 13 between treatment arms (C31 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	0.3273	Mean Difference (Net)	1.25	2-Sided	95	-2.16	4.66	No	Superiority or Other
OG000 OG001	Differences in item 13 between treatment arms (C34 of D1) was analyzed from a two-sample t-test.	t-test, 2 sided	<0.0001	Mean Difference (Net)	0	2-Sided	95	0	0	No	Superiority or Other
OG000 OG001	Differences in item 13 between treatment arms (EOT) was analyzed from a two-sample t-test.	t-test, 2 sided	0.7108	Mean Difference (Net)	-0.06	2-Sided	95	-0.39	0.27	No	Superiority or Other