Study Comparing Inotuzumab Ozogamicin In Combination With... | NCT00562965

NCT00562965

ID	Type	Description	Link
B1931006	Other Identifier	Alias Study Number
2007-000219-27	EudraCT Number

Status Module

Sponsor/Collaborators Module

Name	Class
UCB Pharma	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Subjects will receive rituximab intravenously at a dose level of 375 mg/m² on day 1 of each cycle followed by inotuzumab ozogamicin administered intravenously at a dose level of 1.8 mg/m2 on day 2. The sequence will be repeated every 28 days.	Drug: inotuzumab ozogamicin Drug: rituximab
B	Active Comparator	Subjects will receive the investigator's choice from the following rituximab-containing regimens: R-CVP or R-FND. The investigator's choice of therapy will be administered every 21 days. Dosing for R-CVP will be intravenous rituximab at a dose of 375 mg/m2 on day 1, intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1, intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1, and oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5. Dosing for R-FND will be as follows: rituximab 375 mg/m2 intravenous on day 1, mitoxantrone 10 mg/m2 intravenous on day 2, fludarabine 25 mg/m2 intravenous on days 2 through 4 and oral dexamethasone 20 mg/day on days 1-5.	Drug: rituximab Drug: cyclophosphamide Drug: vincristine Drug: prednisone/prednisolone Drug: mitoxantrone Drug: fludarabine Drug: dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
inotuzumab ozogamicin	Drug	IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS was defined as the time from randomization to disease progression or death due to any cause, whichever occurred first, censored at the last tumor evaluation date. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.44.	Baseline until disease progression or death or up to 1 year after last dose of study drug

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Objective Response (OR)	OR was based on assessment of complete response(CR),unconfirmed CR(Cru),partial response(PR) as per International Response Criteria for Non-Hodgkin's Lymphoma.Confirmed response=response persists on repeat imaging at least 4 weeks after initial response.CR=complete disappearance of all detectable clinical/radiographic evidence of disease,lymph nodes regressed to normal size [at least 1.5 centimeter(cm) or less],spleen regressed,not palpable on physical examination,bone marrow infiltrate cleared on repeat aspiration/biopsy.PR=at least 50 percent (%) decrease in sum of product diameters of 6 greatest dominant nodes,no increase in other nodes,liver/spleen,no new sites of disease. CRu=residual lymph node greater than 1.5 cm in transverse diameter that has regressed more than 75% in product diameter.Individual nodes previously confluent,regressed more than 75% in product diameters.Indeterminate bone marrow (increased number/size of lymph aggregates without cytologic/architectural atypia).

Other Outcomes

Measure	Description	Time Frame
Number of Participants With Clinically Significant Change From Baseline in QT Interval Findings	Assessments of QT interval was performed only in rituximab + inotuzumab ozogamicinin group. QT interval corrected using Fridericia's formula (QTcF) and Bazett's formula (QTcB) was analyzed as per common terminology criteria for adverse events (CTCAE) version 3.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening or disabling AE, Grade 5 = death related to AE. Number of participants with change in CTCAE grading at post-baseline time point compared to the baseline were presented. The post-baseline value was defined as the maximum grade after the first dose date on or before the end of treatment.

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Facey Medical Group		Mission Hills	California	91345	United States
Deaconess Clinic

References Module

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

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rituximab + Inotuzumab Ozogamicin	Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Intent-to-treat population included all participants who were randomized in to the study.

Arm/Group Information

ID	Title	Description
BG000	Rituximab + Inotuzumab Ozogamicin	Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
BG001	Control Regimens R-CVP + R-FND	Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
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
	OG000NA(22.2 to NA)Median and upper limit of confidence interval was not estimable because majority of participants were censored. OG00116.4(7.9 to 28.4)

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	To detect a hazard ratio of 0.77 with 85% power using a 2-sided log-rank test at the 5% significance level, it was planned that approximately 978 participants were needed to be randomized but due to premature termination only 29 participants were randomized.	Cox proportional hazard regression model	A 2-sided 5% significance level on a stratified Cox proportional hazard regression model was used.	0.0358		Hazard Ratio (HR)	0.19			2-Sided	95	0.04	1.02			In this regression model, treatment arm was the covariate and the strata (number of prior regimens, investigator's choice of therapy and geographical region) over which participants were stratified prior to randomization were the variables.

Secondary

Percentage of Participants With Objective Response (OR)

OR was based on assessment of complete response(CR),unconfirmed CR(Cru),partial response(PR) as per International Response Criteria for Non-Hodgkin's Lymphoma.Confirmed response=response persists on repeat imaging at least 4 weeks after initial response.CR=complete disappearance of all detectable clinical/radiographic evidence of disease,lymph nodes regressed to normal size [at least 1.5 centimeter(cm) or less],spleen regressed,not palpable on physical examination,bone marrow infiltrate cleared on repeat aspiration/biopsy.PR=at least 50 percent (%) decrease in sum of product diameters of 6 greatest dominant nodes,no increase in other nodes,liver/spleen,no new sites of disease. CRu=residual lymph node greater than 1.5 cm in transverse diameter that has regressed more than 75% in product diameter.Individual nodes previously confluent,regressed more than 75% in product diameters.Indeterminate bone marrow (increased number/size of lymph aggregates without cytologic/architectural atypia).

Intent-to-treat population included all participants who were randomized in to the study.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, every 6 to 12 weeks during treatment period, end of treatment (EOT) (42 days after last dose), every 12 weeks during follow-up for up to 1 year after the last dose of study drug

ID	Title	Description
OG000	Rituximab + Inotuzumab Ozogamicin	Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.

Secondary

Overall Survival Probability at Months 6, 12 and 24

Overall survival was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. Participants who withdrew or lost to follow-up from study without having death documented were censored at the date of last contact. Kaplan-Meier estimates of the probability of survival at 6, 12 and 24 months was used to estimate the survival function.

Intent-to-treat population included all participants who were randomized in to the study.

Posted

Number

95% Confidence Interval

percent chance of survival

Baseline up to Month 6, 12, 24

ID	Title	Description
OG000	Rituximab + Inotuzumab Ozogamicin	Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
OG001	Control Regimens R-CVP + R-FND	Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.

Secondary

Pharmacokinetics of Inotuzumab Ozogamicin in Combination With Rituximab

Data for this outcome measurement was not collected since pharmacokinetic parameters were not analyzed in this study due to very few number of participants with PK samples.

Posted

0, 1, 168 hours on Cycle 1, 2; 0, 1, 2, 168 hours on Cycle 3, 4

ID	Title	Description
OG000	Rituximab + Inotuzumab Ozogamicin	Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
OG001	Control Regimens R-CVP + R-FND	Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.

Other Pre-specified

Number of Participants With Clinically Significant Change From Baseline in QT Interval Findings

Assessments of QT interval was performed only in rituximab + inotuzumab ozogamicinin group. QT interval corrected using Fridericia's formula (QTcF) and Bazett's formula (QTcB) was analyzed as per common terminology criteria for adverse events (CTCAE) version 3.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening or disabling AE, Grade 5 = death related to AE. Number of participants with change in CTCAE grading at post-baseline time point compared to the baseline were presented. The post-baseline value was defined as the maximum grade after the first dose date on or before the end of treatment.

Safety population included all participants who received at least 1 dose of a test article. Here 'N' signifies those participants who were evaluable for this outcome measure.

Posted

Number

participants

Baseline up to 42 days post-treatment

ID	Title	Description
OG000	Rituximab + Inotuzumab Ozogamicin	Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.

Units	Counts
Participants

Other Pre-specified

Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs)

AE=any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. TEAE=between first dose of study drug and up to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Safety population included all participants who received at least 1 dose of a test article (either rituximab + inotuzumab ozogamicin or control regimens R-CVP + R-FND).

Posted

Number

participants

Baseline up to 42 days post-treatment

ID	Title	Description
OG000	Rituximab + Inotuzumab Ozogamicin	Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
OG001	Control Regimens R-CVP + R-FND	Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.

Other Pre-specified

Number of Participants With Clinically Significant Change From Baseline in Laboratory Findings

Criteria for laboratory test abnormality: Blood Chemistry (alkaline phosphatase [greater than{>}5*upper limit of normal {ULN}, calcium [less than {<}1.75 millimole per liter {mmol/L}, creatinine [>3*ULN], glucose [>13.9 mmol/L], phosphorous [<0.6 mmol/L], potassium [<3 mmol/L], aspartate transaminase [>5.0*ULN], total bilirubin [>3*ULN]), Coagulation (international normalized ratio [>2*ULN]), Hematology (hemoglobin [<80 grams/Liter], lymphocytes [<0.5*10^9/L], absolute neutrophil count [<1*10^9/L], platelet count [<50*10^9/L], WBC [<2.0*10^9/L]).](streamdown:incomplete-link)

Safety population included all participants who received at least 1 dose of a test article (either rituximab + inotuzumab ozogamicin or control regimens R-CVP + R-FND).

Posted

Number

participants

Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)

ID	Title	Description
OG000	Rituximab + Inotuzumab Ozogamicin	Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
OG001	Control Regimens R-CVP + R-FND	Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.

Other Pre-specified

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Criteria for determining significant change from baseline in vital signs abnormalities: heart rate value of <40 beats per minute and value >150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, and body weight>=10% increase or decrease of body weight in kilogram (kg).

Safety population included all participants who received at least 1 dose of a test article (either rituximab + inotuzumab ozogamicin or control regimens R-CVP + R-FND).

Posted

Number

participants

Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)

ID	Title	Description
OG000	Rituximab + Inotuzumab Ozogamicin	Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
OG001	Control Regimens R-CVP + R-FND	Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.

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	Rituximab + Inotuzumab Ozogamicin	Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.			6	15	15	15
EG001	Control Regimens R-CVP + R-FND	Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.			6	13	13	13

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0013 affected13 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0012 affected13 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Asthenia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Chills	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Pyrexia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Venoocclusive liver disease	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Cellulitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0012 affected13 at risk
Pneumonia cryptococcal	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Sepsis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected13 at risk
Viral infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Blood creatinine increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Lipase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0017 affected13 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Hypercoagulation	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected13 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0015 affected13 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0012 affected13 at risk
Monocytosis	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected15 at risk EG00111 affected13 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected15 at risk EG0017 affected13 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Extrasystoles	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Palpitations	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected13 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Eye disorder	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected15 at risk EG0010 affected13 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected15 at risk EG0012 affected13 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0015 affected13 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0012 affected13 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Gastritis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected15 at risk EG0017 affected13 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Oral pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected13 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected13 at risk
Asthenia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected13 at risk
Chest pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Chills	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected15 at risk EG0010 affected13 at risk
Fatigue	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected15 at risk EG0013 affected13 at risk
Feeling cold	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Generalised oedema	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Influenza like illness	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Malaise	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Mucosal inflammation	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Oedema	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Oedema peripheral	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected13 at risk
Pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0012 affected13 at risk
Pyrexia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected15 at risk EG0013 affected13 at risk
Thirst	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected15 at risk EG0013 affected13 at risk
Bronchitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Cystitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Device related infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Ear infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Folliculitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Fungal infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Herpes zoster	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Influenza	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0012 affected13 at risk
Localised infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0012 affected13 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected13 at risk
Rhinitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Sinusitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0012 affected13 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Alanine aminotransferase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected15 at risk EG0012 affected13 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0006 affected15 at risk EG0012 affected13 at risk
Bilirubin conjugated increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Blood albumin decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0012 affected13 at risk
Blood albumin increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0005 affected15 at risk EG0012 affected13 at risk
Blood amylase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Blood bicarbonate decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Blood bicarbonate increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Blood calcium decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0012 affected13 at risk
Blood chloride decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Blood chloride increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Blood creatinine decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Blood glucose increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0013 affected13 at risk
Blood lactate dehydrogenase decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected13 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected15 at risk EG0011 affected13 at risk
Blood phosphorus decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Blood phosphorus increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0013 affected13 at risk
Blood potassium decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0013 affected13 at risk
Blood sodium decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0012 affected13 at risk
Blood sodium increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Blood urea decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected13 at risk
Blood urea increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0012 affected13 at risk
Blood uric acid decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Blood uric acid increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected15 at risk EG0010 affected13 at risk
Haemoglobin decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected13 at risk
Lymphocyte count decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Neutrophil count	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Neutrophil count decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
PCO2 decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
PCO2 increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Protein total decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected13 at risk
Red blood cell count decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Urine output decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected13 at risk
White blood cell count decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected15 at risk EG0013 affected13 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected13 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected13 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected15 at risk EG0014 affected13 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Hypouricaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0012 affected13 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected13 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0012 affected13 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected13 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected13 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected13 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Dysgeusia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0012 affected13 at risk
Headache	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected15 at risk EG0012 affected13 at risk
Memory impairment	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0012 affected13 at risk
Paraesthesia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected15 at risk EG0011 affected13 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Insomnia	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0013 affected13 at risk
Chromaturia	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Dysuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected13 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Proteinuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected15 at risk EG0015 affected13 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0013 affected13 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected15 at risk EG0010 affected13 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected13 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected13 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0012 affected13 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected13 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0012 affected13 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected13 at risk
Hot flush	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected13 at risk
Hypertension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected13 at risk
Hypotension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected13 at risk

Study did not met estimated enrollment of approximately 978 participants,thus analysis and conclusions were limited by small number of enrolled participants.Termination was not prompted by identification of safety concerns with inotuzumab ozogamicin.

Certain Agreements

ID	Term
D008224	Lymphoma, Follicular

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D000080045	Inotuzumab Ozogamicin
D000069283	Rituximab
D003520	Cyclophosphamide
D014750	Vincristine
D011241	Prednisone
D011239	Prednisolone
D008942	Mitoxantrone
C024352	fludarabine
D003907	Dexamethasone

Ancestor Terms

ID	Term
D000080084	Calicheamicins
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
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
D058846	Antibodies, Monoclonal, Murine-Derived
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D054836	Indolizidines
D007212	Indolizines
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011246	Pregnadienetriols
D000880	Anthraquinones
D000095322	Anthrones
D000873	Anthracenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D011809	Quinones
D013259	Steroids, Fluorinated

Units	Counts
Participants	OG0000 OG0010