Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00868608
• Collaborator: UCB Pharma (Industry)
• Enrollment: 81
• Locations: 42
• Arm: 1
• Actual Duration (Months): 46.9
• Patients Per Site: 1.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: Inotuzumab Ozogamicin (CMC-544)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study Of Inotuzumab Ozogamicin (Cmc-544) In Subjects With Indolent Non-hodgkin's Lymphoma (Nhl) That Is Refractory To Or Has Relapsed After Rituximab And Chemotherapy Or Radioimmunotherapy
• Actual Study Start Date: Jul 30, 2009
• Actual Primary Completion Date: Jan 10, 2012
• Actual Study Completion Date: Jun 27, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: inotuzumab ozogamicin inotuzumab ozogamicin	Drug: Inotuzumab Ozogamicin (CMC-544); Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles; Other Names: inotuzumab ozogamicin

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL [Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.]

   CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 cm in their greatest transverse diameter [GTD] for nodes more than [>]1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by greater than or equal to [≥]50% in the SPD or GTD (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.

Secondary Outcome Measures

1. Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL [Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.]

   CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or greatest transverse diameter (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.

2. Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL [Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.]

   CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.

3. Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL [Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.]

   CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.

4. Duration of Response in Participants With Indolent NHL [Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.]

   Duration of response was measured from the first date of response until the first date that the objective progression of disease (PD) or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

5. Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL [6, 12 and 24 months]

   Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

6. Duration of Response in Participants With Follicular NHL [Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.]

   Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

7. Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL [6, 12 and 24 months]

   Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

8. Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHL [Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.]

   Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

9. Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Indolent NHL [6, 12 and 24 months]

   Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

10. Kaplan-Meier Estimate of the PFS in Participants With Follicular NHL [Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.]

    Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

11. Kaplan-Meier Estimate of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Follicular NHL [6, 12 and 24 months]

    Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.

12. Kaplan-Meier Estimate of the Overall Survival (OS) in Participants With Indolent NHL [Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.]

    Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.

13. Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL [6, 12 and 24 months]

    Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.

14. Kaplan-Meier Estimate of the OS in Participants With Follicular NHL [Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.]

    Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.

15. Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL [6, 12 and 24 months]

    Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.

16. Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax) [Cycle 1: pre-dose, 1 hour; Cycle 3 & 4: pre-dose, 1, 3, 48, 168 hours; Cycle 6 (if applicable): pre-dose; end of treatment: during clinic visit]

    Triplicate 12-lead electrocardiogram (ECG) measurements were performed approximately 2 minutes apart. ECG assessments were pre-specified in the protocol to be time-matched with selected pharmacokinetic (PK) samples in order to conduct a concentration-QTc analysis. A study-specific QT correction factor was estimated using the un-averaged triplicate data and was used to calculate the study-specific corrected QT (QTcS). QTcS interval versus serum concentrations were modeled using a population analysis approach to identify potential effects of total calicheamicin exposure. Results for drug effects were based on the median Cmax for total calicheamicin across all participants: median Cmax was 61.3 ng/mL

17. Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population) [Protocol reporting period: from informed consent to at least 28 days after the last dose.]

    Includes all TEAEs: any event that emerged after the first dose of the study treatment during the treatment period that was absent before administration of any study treatment, or worsened during the treatment period relative to the pre-treatment state.

18. Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population) [Screening; Cycle 1: pre-dose & 1 hour; Cycles 3 and 4: pre-dose, 1, 3, 48, and 168 hours; Cycle 6: pre-dose; end of treatment: 28 to 56 days post-last dose.]

    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Maximum QTcF was categorized as less than or equal to (≤) 450 msec, >450 msec to ≤480 msec, >480 msec to ≤500 msec and >500 msec. Participants are reported only once under the maximum QTcF interval observed at any of the time-points. Maximum increase from baseline was categorized as <30 msec, ≥30 to <60 msec (borderline) and ≥60 msec (prolonged) were summarized.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.

• Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.

• Measurable disease with adequate bone marrow function, renal and hepatic function

Exclusion Criteria:

• History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.

• Prior allogeneic hematopoietic stem cell transplant (HSCT).

• Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Birmingham	Birmingham	Alabama	United States	35294-3300
2	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-3330
3	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294
4	Loma Linda University Cancer Center	Loma Linda	California	United States	92350 1700
5	Loma Linda University Cancer Center #5	Loma Linda	California	United States	92354
6	Loma Linda University Medical Center	Loma Linda	California	United States	92354
7	Facey Medical Group	Mission Hills	California	United States	91345
8	Providence Holy Cross	Mission Hills	California	United States	91345
9	Rush University Medical Center	Chicago	Illinois	United States	60612
10	Park Nicollet Frauenshuh Cancer Center	Saint Louis Park	Minnesota	United States	55426
11	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
12	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
13	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
14	John Theurer Cancer Center	Hackensack	New Jersey	United States	07601
15	New York Medical College	Hawthorne	New York	United States	10532
16	Quest Diagnostics	Allentown	Pennsylvania	United States	18103-6205
17	Carlisle Regional Medical Center Lab	Carlisle	Pennsylvania	United States	17015
18	Penn State Milton S. Hershey medical Center	Hershey	Pennsylvania	United States	17033-0850
19	Lewistown Hospital	Lewistown	Pennsylvania	United States	17044
20	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111-2497
21	CMSA Medical Lab	State College	Pennsylvania	United States	16803
22	University of Texas, MD Anderson Cancer Center	Houston	Texas	United States	77030-4009
23	Universitair Ziekenhuis Gent	Gent		Belgium	9000
24	Universitaire Ziekenhuizen UZ Gasthuisberg	Leuven		Belgium	3000
25	Oncologisch Centrum GZA - Location St. Augustinus	Wilrijk		Belgium	2610
26	Charite Campus Mitte	Berlin		Germany	10117
27	Charite Berlin-Campus Virchow-Klinikum	Berlin		Germany	13353
28	The Chinese University of Hong Kong, Prince of Wales Hospital	Shatin, N.T.		Hong Kong
29	Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Belgyogyaszati Intezet,	Debrecen		Hungary	4012
30	Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly	Kaposvar		Hungary	7400
31	National Cancer Center Hospital East	Kashiwa	Chiba	Japan	277-8577
32	National Cancer Center Hospital	Chuo-ku	Tokyo	Japan	104-0045
33	EPMint Co., Ltd	Aichi		Japan	460-0003
34	Nagoya Daini Red Cross Hospital	Aichi		Japan	466-8650
35	National Hospital Organization Kyushu Cancer Center	Fukuoka		Japan	811-1395
36	National Hp. Org. Kyushu Medical Center	Fukuoka		Japan
37	Tokai University Hospital	Kanagawa		Japan	259-1193
38	Cancer Inst. Hp. of Japanese Foundation for Cancer Research	Tokyo		Japan	135-8550
39	Samsung Medical Center	Seoul	Korea	Korea, Republic of	135-710
40	Erasmus Medisch Centrum	Rotterdam		Netherlands	3015 CE
41	Erasmus MC Apotheek	Rotterdam		Netherlands	3015 GD
42	Singapore General Hospital	Singapore		Singapore	169 608

Sponsors and Collaborators

• Pfizer
• UCB Pharma

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00868608
• Other Study ID Numbers: 3129K7-2001; B1931007; 2008-001635-34
• First Posted: Mar 25, 2009
• Last Update Posted: Oct 31, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Pfizer: Refractory Indolent NHL; lymphoma
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Inotuzumab Ozogamicin

Study Results

Participant Flow

Arm/Group Title	Inotuzumab Ozogamicin - NHL Type (Follicular)	Inotuzumab Ozogamicin - NHL Type (Marginal Zone)	Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent Non-Hodgkin's Lymphoma (NHL) defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 percent [%] of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Period Title: Overall Study
STARTED	72	4	5
COMPLETED	49	1	0
NOT COMPLETED	23	3	5

Baseline Characteristics

Arm/Group Title	Inotuzumab Ozogamicin - NHL Type (Follicular)	Inotuzumab Ozogamicin - NHL Type (Marginal Zone)	Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)	Total
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 % of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.	Total of all reporting groups
Overall Participants	72	4	5	81
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	60.5 (10.2)	70.8 (13.5)	65.2 (10.0)	61.3 (10.5)
Sex: Female, Male (Count of Participants)
Female	35 48.6%	2 50%	0 0%	37 45.7%
Male	37 51.4%	2 50%	5 100%	44 54.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL
Description	CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 cm in their greatest transverse diameter [GTD] for nodes more than [>]1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by greater than or equal to [≥]50% in the SPD or GTD (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.
Time Frame	Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population: all participants who were enrolled into the study.

Arm/Group Title	Inotuzumab Ozogamicin - Total (All NHL Types)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	81
Number (95% Confidence Interval) [Percentage of Participants]	66.7 92.6%

2. Secondary Outcome

Title	Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL
Description	CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or greatest transverse diameter (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.
Time Frame	Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Outcome Measure Data

Analysis Population Description

ITT population (participants with NHL type defined as follicular).

Arm/Group Title	Inotuzumab Ozogamicin - NHL Type (Follicular)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	72
Number (95% Confidence Interval) [Percentage of Participants]	70.8 98.3%

3. Secondary Outcome

Title	Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL
Description	CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.
Time Frame	Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Inotuzumab Ozogamicin - Total (All NHL Types)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	81
Number (95% Confidence Interval) [Percentage of Participants]	30.9 42.9%

4. Secondary Outcome

Title	Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL
Description	CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.
Time Frame	Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Outcome Measure Data

Analysis Population Description

ITT population (participants with NHL type defined as follicular).

Arm/Group Title	Inotuzumab Ozogamicin - NHL Type (Follicular)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles (in participants who achieved a CR). After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	72
Number (95% Confidence Interval) [Percentage of Participants]	34.7 48.2%

5. Secondary Outcome

Title	Duration of Response in Participants With Indolent NHL
Description	Duration of response was measured from the first date of response until the first date that the objective progression of disease (PD) or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Time Frame	Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Outcome Measure Data

Analysis Population Description

Participants with Indolent NHL who responded.

Arm/Group Title	Inotuzumab Ozogamicin - Total (All NHL Types)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	54
Median (95% Confidence Interval) [Months]	24.8

6. Secondary Outcome

Title	Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL
Description	Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Time Frame	6, 12 and 24 months

Outcome Measure Data

Analysis Population Description

Participants with Indolent NHL who responded.

Arm/Group Title	Inotuzumab Ozogamicin - Total (All NHL Types)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	54
6 Month Probability of Maintaining a Response	0.82
12 Month Probability of Maintaining a Response	0.65
24 Month Probability of Maintaining a Response	0.53

7. Secondary Outcome

Title	Duration of Response in Participants With Follicular NHL
Description	Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Time Frame	Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Outcome Measure Data

Analysis Population Description

Participants with Follicular NHL who responded.

Arm/Group Title	Inotuzumab Ozogamicin - NHL Type (Follicular)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	51
Median (95% Confidence Interval) [Months]	24.8

8. Secondary Outcome

Title	Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL
Description	Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Time Frame	6, 12 and 24 months

Outcome Measure Data

Analysis Population Description

Participants with Follicular NHL who responded.

Arm/Group Title	Inotuzumab Ozogamicin - NHL Type (Follicular)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	51
6 Month Probability of Maintaining a Response	0.85
12 Month Probability of Maintaining a Response	0.67
24 Month Probability of Maintaining a Response	0.57

9. Secondary Outcome

Title	Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHL
Description	Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Time Frame	Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Inotuzumab Ozogamicin - Total (All NHL Types)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	81
Median (95% Confidence Interval) [Months]	12.7

10. Secondary Outcome

Title	Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Indolent NHL
Description	Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Time Frame	6, 12 and 24 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Inotuzumab Ozogamicin - Total (All NHL Types)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	81
6 Months	65.1
12 Months	52.0
24 Months	41.3

11. Secondary Outcome

Title	Kaplan-Meier Estimate of the PFS in Participants With Follicular NHL
Description	Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Time Frame	Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Outcome Measure Data

Analysis Population Description

ITT population (participants with NHL type defined as follicular).

Arm/Group Title	Inotuzumab Ozogamicin - NHL Type (Follicular)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	72
Median (95% Confidence Interval) [Months]	14.7

12. Secondary Outcome

Title	Kaplan-Meier Estimate of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Follicular NHL
Description	Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Time Frame	6, 12 and 24 months

Outcome Measure Data

Analysis Population Description

ITT population (participants with NHL type defined as follicular).

Arm/Group Title	Inotuzumab Ozogamicin - NHL Type (Follicular)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	72
6 Months	69.3
12 Months	56.3
24 Months	46.1

13. Secondary Outcome

Title	Kaplan-Meier Estimate of the Overall Survival (OS) in Participants With Indolent NHL
Description	Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.
Time Frame	Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Inotuzumab Ozogamicin - Total (All NHL Types)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	81
Median (95% Confidence Interval) [Months]	NA

14. Secondary Outcome

Title	Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL
Description	Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.
Time Frame	6, 12 and 24 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Inotuzumab Ozogamicin - Total (All NHL Types)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	81
6 Months	0.89
12 Months	0.80
24 Months	0.73

15. Secondary Outcome

Title	Kaplan-Meier Estimate of the OS in Participants With Follicular NHL
Description	Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.
Time Frame	Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Outcome Measure Data

Analysis Population Description

ITT population (participants with NHL type defined as follicular).

Arm/Group Title	Inotuzumab Ozogamicin - NHL Type (Follicular)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	72
Median (95% Confidence Interval) [Months]	NA

16. Secondary Outcome

Title	Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL
Description	Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.
Time Frame	6, 12 and 24 months

Outcome Measure Data

Analysis Population Description

ITT population (participants with NHL type defined as follicular).

Arm/Group Title	Inotuzumab Ozogamicin - NHL Type (Follicular)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	72
6 Months	0.91
12 Months	0.83
24 Months	0.78

17. Secondary Outcome

Title	Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax)
Description	Triplicate 12-lead electrocardiogram (ECG) measurements were performed approximately 2 minutes apart. ECG assessments were pre-specified in the protocol to be time-matched with selected pharmacokinetic (PK) samples in order to conduct a concentration-QTc analysis. A study-specific QT correction factor was estimated using the un-averaged triplicate data and was used to calculate the study-specific corrected QT (QTcS). QTcS interval versus serum concentrations were modeled using a population analysis approach to identify potential effects of total calicheamicin exposure. Results for drug effects were based on the median Cmax for total calicheamicin across all participants: median Cmax was 61.3 ng/mL
Time Frame	Cycle 1: pre-dose, 1 hour; Cycle 3 & 4: pre-dose, 1, 3, 48, 168 hours; Cycle 6 (if applicable): pre-dose; end of treatment: during clinic visit

Outcome Measure Data

Analysis Population Description

There were 80 participants in the analysis dataset, but time-matched PK-ECG data only existed for 73 participants (35 female).

Arm/Group Title	Inotuzumab Ozogamicin - Total (All NHL Types)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	80
Cycle 1	3.51
Cycle 2	5.00
Cycle 3	6.41
Cycle 4	7.83

18. Secondary Outcome

Title	Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
Description	Includes all TEAEs: any event that emerged after the first dose of the study treatment during the treatment period that was absent before administration of any study treatment, or worsened during the treatment period relative to the pre-treatment state.
Time Frame	Protocol reporting period: from informed consent to at least 28 days after the last dose.

Outcome Measure Data

Analysis Population Description

Safety Population - includes all participants who received at least 1 dose of study medication. This population only excluded participants who never received any study medication.

Arm/Group Title	Inotuzumab Ozogamicin - Total (All NHL Types)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	81
% participants with a TEAE	96.3 133.8%
% participants with serious TEAE	18.5 25.7%
% participants with Grade 3 or higher TEAE	77.8 108.1%
% participants for study drug discontinuation	58.0 80.6%
% participants with dose reduction due to TEAE	33.3 46.3%
% participants for study drug stopped temporarily	48.1 66.8%

19. Secondary Outcome

Title	Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population)
Description	Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Maximum QTcF was categorized as less than or equal to (≤) 450 msec, >450 msec to ≤480 msec, >480 msec to ≤500 msec and >500 msec. Participants are reported only once under the maximum QTcF interval observed at any of the time-points. Maximum increase from baseline was categorized as <30 msec, ≥30 to <60 msec (borderline) and ≥60 msec (prolonged) were summarized.
Time Frame	Screening; Cycle 1: pre-dose & 1 hour; Cycles 3 and 4: pre-dose, 1, 3, 48, and 168 hours; Cycle 6: pre-dose; end of treatment: 28 to 56 days post-last dose.

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Inotuzumab Ozogamicin - Total (All NHL Types)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
Measure Participants	81
% participants with QTcF ≤450 ([msec)	83.1 115.4%
% participants with QTcF >450 to ≤480 (msec)	14.3 19.9%
% participants with QTcF >480 to ≤500 (msec)	2.6 3.6%
% participants with QTcF >500 (msec)	0 0%
% participants with any baseline increase	98.7 137.1%
% participants baseline increase <30 (msec)	79.2 110%
% participants baseline increase ≥30 to <60 (msec)	18.2 25.3%
% participants baseline increase ≥60 (msec)	1.3 1.8%

Adverse Events

Time Frame	Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose.
Adverse Event Reporting Description	The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Inotuzumab Ozogamicin - NHL Type (Follicular)		Inotuzumab Ozogamicin - NHL Type (Marginal Zone)		Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)
Arm/Group Description	Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 % of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.		Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.		Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
All Cause Mortality
	Inotuzumab Ozogamicin - NHL Type (Follicular)		Inotuzumab Ozogamicin - NHL Type (Marginal Zone)		Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Inotuzumab Ozogamicin - NHL Type (Follicular)		Inotuzumab Ozogamicin - NHL Type (Marginal Zone)		Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/72 (16.7%)		2/4 (50%)		1/5 (20%)
Gastrointestinal disorders
Abdominal distension	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Abdominal pain upper	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Ascites	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Constipation	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Dysphagia	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Intestinal obstruction	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Nausea	0/72 (0%)		1/4 (25%)		0/5 (0%)
General disorders
Fatigue	0/72 (0%)		1/4 (25%)		0/5 (0%)
Pyrexia	2/72 (2.8%)		0/4 (0%)		1/5 (20%)
Hepatobiliary disorders
Budd-Chiari syndrome	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Cholelithiasis	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Hepatic function abnormal	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Hyperbilirubinaemia	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Infections and infestations
Catheter site infection	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Peritonitis	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Pneumonia	2/72 (2.8%)		1/4 (25%)		1/5 (20%)
Sepsis	2/72 (2.8%)		0/4 (0%)		0/5 (0%)
Staphylococcal bacteraemia	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Metabolism and nutrition disorders
Decreased appetite	0/72 (0%)		1/4 (25%)		0/5 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma	0/72 (0%)		1/4 (25%)		0/5 (0%)
Nervous system disorders
Syncope	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Renal and urinary disorders
Hydronephrosis	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Urinary retention	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Epistaxis	1/72 (1.4%)		0/4 (0%)		0/5 (0%)
Pneumonia aspiration	0/72 (0%)		0/4 (0%)		1/5 (20%)
Other (Not Including Serious) Adverse Events
	Inotuzumab Ozogamicin - NHL Type (Follicular)		Inotuzumab Ozogamicin - NHL Type (Marginal Zone)		Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	69/72 (95.8%)		4/4 (100%)		5/5 (100%)
Blood and lymphatic system disorders
Anaemia	12/72 (16.7%)		0/4 (0%)		0/5 (0%)
Leukopenia	26/72 (36.1%)		2/4 (50%)		1/5 (20%)
Lymphopenia	25/72 (34.7%)		2/4 (50%)		1/5 (20%)
Neutropenia	40/72 (55.6%)		1/4 (25%)		4/5 (80%)
Thrombocytopenia	55/72 (76.4%)		3/4 (75%)		2/5 (40%)
Cardiac disorders
Atrial fibrillation	2/72 (2.8%)		0/4 (0%)		1/5 (20%)
Cardiac failure	0/72 (0%)		0/4 (0%)		1/5 (20%)
Ear and labyrinth disorders
Vertigo	0/72 (0%)		1/4 (25%)		0/5 (0%)
Eye disorders
Visual impairment	1/72 (1.4%)		0/4 (0%)		1/5 (20%)
Gastrointestinal disorders
Abdominal distension	6/72 (8.3%)		0/4 (0%)		1/5 (20%)
Abdominal pain	8/72 (11.1%)		1/4 (25%)		1/5 (20%)
Abdominal pain lower	1/72 (1.4%)		1/4 (25%)		0/5 (0%)
Abdominal pain upper	6/72 (8.3%)		1/4 (25%)		0/5 (0%)
Constipation	12/72 (16.7%)		1/4 (25%)		1/5 (20%)
Diarrhoea	8/72 (11.1%)		0/4 (0%)		0/5 (0%)
Dry mouth	1/72 (1.4%)		0/4 (0%)		1/5 (20%)
Dyspepsia	2/72 (2.8%)		0/4 (0%)		1/5 (20%)
Gastrooesophageal reflux disease	3/72 (4.2%)		0/4 (0%)		1/5 (20%)
Haemorrhoids	0/72 (0%)		0/4 (0%)		1/5 (20%)
Nausea	35/72 (48.6%)		2/4 (50%)		1/5 (20%)
Oesophagitis	0/72 (0%)		1/4 (25%)		0/5 (0%)
Stomatitis	4/72 (5.6%)		0/4 (0%)		0/5 (0%)
Vomiting	14/72 (19.4%)		0/4 (0%)		1/5 (20%)
General disorders
Chills	6/72 (8.3%)		0/4 (0%)		0/5 (0%)
Early satiety	0/72 (0%)		0/4 (0%)		1/5 (20%)
Fatigue	34/72 (47.2%)		3/4 (75%)		2/5 (40%)
Oedema peripheral	7/72 (9.7%)		0/4 (0%)		0/5 (0%)
Pyrexia	14/72 (19.4%)		1/4 (25%)		0/5 (0%)
Hepatobiliary disorders
Hyperbilirubinaemia	11/72 (15.3%)		1/4 (25%)		0/5 (0%)
Infections and infestations
Genital infection fungal	0/72 (0%)		0/4 (0%)		1/5 (20%)
Nasopharyngitis	8/72 (11.1%)		0/4 (0%)		0/5 (0%)
Oral candidiasis	0/72 (0%)		0/4 (0%)		1/5 (20%)
Pneumonia	2/72 (2.8%)		1/4 (25%)		0/5 (0%)
Sinusitis	5/72 (6.9%)		1/4 (25%)		0/5 (0%)
Upper respiratory tract infection	9/72 (12.5%)		1/4 (25%)		0/5 (0%)
Urinary tract infection	5/72 (6.9%)		0/4 (0%)		0/5 (0%)
Injury, poisoning and procedural complications
Arthropod bite	0/72 (0%)		0/4 (0%)		1/5 (20%)
Investigations
Alanine aminotransferase increased	16/72 (22.2%)		0/4 (0%)		0/5 (0%)
Aspartate aminotransferase increased	32/72 (44.4%)		2/4 (50%)		1/5 (20%)
Blood alkaline phosphatase increased	21/72 (29.2%)		1/4 (25%)		0/5 (0%)
Blood chloride increased	0/72 (0%)		0/4 (0%)		1/5 (20%)
Blood creatinine increased	5/72 (6.9%)		0/4 (0%)		1/5 (20%)
Blood lactate dehydrogenase increased	5/72 (6.9%)		1/4 (25%)		0/5 (0%)
Blood magnesium decreased	0/72 (0%)		0/4 (0%)		1/5 (20%)
Blood potassium decreased	0/72 (0%)		0/4 (0%)		1/5 (20%)
Blood urea increased	0/72 (0%)		0/4 (0%)		1/5 (20%)
Gamma-glutamyltransferase increased	21/72 (29.2%)		0/4 (0%)		0/5 (0%)
Lymphocyte count increased	0/72 (0%)		0/4 (0%)		1/5 (20%)
Monocyte count increased	2/72 (2.8%)		1/4 (25%)		0/5 (0%)
Protein urine present	0/72 (0%)		0/4 (0%)		2/5 (40%)
Metabolism and nutrition disorders
Decreased appetite	20/72 (27.8%)		2/4 (50%)		1/5 (20%)
Hyperglycaemia	9/72 (12.5%)		1/4 (25%)		1/5 (20%)
Hyperuricaemia	2/72 (2.8%)		0/4 (0%)		1/5 (20%)
Hypoalbuminaemia	10/72 (13.9%)		1/4 (25%)		0/5 (0%)
Hypocalcaemia	5/72 (6.9%)		1/4 (25%)		0/5 (0%)
Hypoglycaemia	2/72 (2.8%)		1/4 (25%)		0/5 (0%)
Hypokalaemia	8/72 (11.1%)		0/4 (0%)		0/5 (0%)
Hypomagnesaemia	4/72 (5.6%)		0/4 (0%)		0/5 (0%)
Hyponatraemia	4/72 (5.6%)		1/4 (25%)		0/5 (0%)
Hypophosphataemia	9/72 (12.5%)		0/4 (0%)		0/5 (0%)
Hypoproteinaemia	0/72 (0%)		0/4 (0%)		1/5 (20%)
Musculoskeletal and connective tissue disorders
Arthralgia	9/72 (12.5%)		0/4 (0%)		1/5 (20%)
Back pain	4/72 (5.6%)		0/4 (0%)		0/5 (0%)
Neck pain	1/72 (1.4%)		1/4 (25%)		0/5 (0%)
Pain in extremity	2/72 (2.8%)		0/4 (0%)		1/5 (20%)
Nervous system disorders
Dizziness	4/72 (5.6%)		0/4 (0%)		1/5 (20%)
Dysgeusia	5/72 (6.9%)		0/4 (0%)		0/5 (0%)
Headache	12/72 (16.7%)		1/4 (25%)		0/5 (0%)
Somnolence	0/72 (0%)		0/4 (0%)		1/5 (20%)
Psychiatric disorders
Delirium	0/72 (0%)		0/4 (0%)		1/5 (20%)
Insomnia	8/72 (11.1%)		0/4 (0%)		0/5 (0%)
Renal and urinary disorders
Dysuria	4/72 (5.6%)		0/4 (0%)		0/5 (0%)
Proteinuria	1/72 (1.4%)		1/4 (25%)		0/5 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	12/72 (16.7%)		1/4 (25%)		1/5 (20%)
Dyspnoea	5/72 (6.9%)		1/4 (25%)		2/5 (40%)
Epistaxis	6/72 (8.3%)		0/4 (0%)		0/5 (0%)
Productive cough	1/72 (1.4%)		0/4 (0%)		1/5 (20%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	0/72 (0%)		0/4 (0%)		1/5 (20%)
Petechiae	4/72 (5.6%)		0/4 (0%)		0/5 (0%)
Rash	9/72 (12.5%)		0/4 (0%)		0/5 (0%)

Limitations/Caveats

The sample size for this study was determined by clinical rather than statistical considerations.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.