A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Terminated

CT.gov ID

NCT00642941

Collaborator

Sarcoma Alliance for Research through Collaboration (Other)

317

Enrollment

Locations

Arms

74.1

Actual Duration (Months)

7.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study was primarily designed to determine objective response, progression-free survival (PFS), and the safety and tolerability of R1507 in participants with recurrent or refractory Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas including alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: RG1507	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

317 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Trial of R1507, a Recombinant Human Monoclonal Antibody to the Insulin-Like Growth Factor-1 Receptor for the Treatment of Participants With Recurrent or Refractory Ewing's Sarcoma, Osteosarcoma, Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas.

Actual Study Start Date :

Dec 18, 2007

Actual Primary Completion Date :

Feb 19, 2014

Actual Study Completion Date :

Feb 19, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1: Ewings Sarcoma Primary Cohort Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.	Drug: RG1507 Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Experimental: Cohort 2: Ewings Sarcoma Secondary Cohort Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.	Drug: RG1507 Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Experimental: Cohort 3: Ewings Sarcoma Expanded Cohort Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.	Drug: RG1507 Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Experimental: Cohort 4: Osteosarcoma Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.	Drug: RG1507 Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Experimental: Cohort 5: Synovial Sarcoma Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.	Drug: RG1507 Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Experimental: Cohort 6: Rhabdomyosarcoma Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.	Drug: RG1507 Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Experimental: Cohort 7a: Alveolar Soft Part Sarcoma Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a includes individuals with alveolar soft part sarcoma.	Drug: RG1507 Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Experimental: Cohort 7b: Desmoplastic Small Round Cell Tumors. Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.	Drug: RG1507 Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Experimental: Cohort 7c: Extraskeletal Myxoid Chondrosarcoma Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.	Drug: RG1507 Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Experimental: Cohort 7d: Clear Cell Sarcoma Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.	Drug: RG1507 Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Experimental: Cohort 7e: Myxoid Liposarcoma Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.	Drug: RG1507 Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Experimental: Cohort 8: Diagnosis Not Specified Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.	Drug: RG1507 Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 [Baseline up to 6 years (assessed at baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression)]
Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is >=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive.
Progression-Free Survival (PFS) Rate According to WHO Response Criteria at 18 Weeks From Start of R2607 Treatment in Cohort 1 [Baseline up to 18 weeks (assessed at baseline, every 6 weeks until disease progression)]
The PFS survival rate is a landmark analysis of progression-free survival at 18 weeks from start of treatment. Progression-free survival rate at 18 weeks is a dichotomous endpoint, with a patient categorized as alive (with either stable disease or objective response) at 18 weeks from start of treatment.
Percentage of Participants With Adverse Events (AEs) in Cohort 1 and 2 [Baseline up to 6 years]

Secondary Outcome Measures

Percentage of Participants With Complete or Partial Response According to WHO Response Criteria in Cohort 1 [Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)]
Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is >=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive.
PFS Rate According to WHO Response Criteria at 18 Weeks From Start of R1507 Treatment in Cohorts 2 to 8 [Baseline, every 6 weeks until disease progression (up to 18 weeks)]
The PFS survival rate is a landmark analysis of progression-free survival at 18 weeks from start of treatment. Progression-free survival rate at 18 weeks is a dichotomous endpoint, with a patient categorized as alive (with either stable disease or objective response at 18 weeks) from start of treatment.
Percentage of Participants With AEs in Cohorts 3-8 [Baseline up to 6 years]
Duration of Response (DOR) According to WHO Response Criteria in Cohorts 1 to 8 [Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)]
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is >=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive.
Time to Progression (TTP) According to WHO Response Criteria in Cohorts 1 to 8 [Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)]
TTP is defined as the time from date of randomization until objective tumor progression. According to the WHO Response Criteria, objective tumor progression is > 25% increase in the area of one or more measurable lesions or the appearance of new lesions.
Failure-Free Survival (FFS) According to WHO Response Criteria in Cohorts 1 to 8 [Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)]
FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause.
Overall Survival (OS) in Cohorts 1 to 8 [Baseline until death (up to 6 years)]
OS was measured from the time of study registration to the date of death or was censored at the date of last contact.
PFS According to WHO Response Criteria in Cohorts 1 to 8 [Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)]
PFS is defined as the duration of time from start of treatment to time of objective progression or death.
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of R1507 [Predose (0 hours [h]), end of 60-90 minutes infusion (EOI), postdose (2, 24, 72-96 h) in Week 1; predose (0 h) and EOI in Weeks 2, 4, 6, 9; predose (0 h), EOI, postdose (48 h) in Week 12; predose (0 h) in Week 13, at final visit (up to 6 years)]
Pharmacokinetics: Clearance (CL) of R1507 [Predose (0 h), EOI (infusion over 60-90 minutes), postdose (2, 24, 72-96 h) in Week 1; predose (0 h) and EOI in Weeks 2, 4, 6, 9; predose (0 h), EOI, postdose (48 h) in Week 12; predose (0 h) in Week 13, at final visit (up to 6 years)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

progressive, recurrent or refractory Ewing's sarcoma, or recurrent or refractory osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcomas of the following sub-types: alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma and myxoid liposarcoma;
Cohort 3 only: age must be >= 2 and <= 21 years

Exclusion Criteria:

clinically significant unrelated systemic illness which would compromise the participant's ability to tolerate the investigational agent, or interfere with the study procedures or results;
known hypersensitivity to any of the components of R1507 or prior hypersensitivity reactions to monoclonal antibodies;
treatment (within the past 2 weeks) with pharmacologic doses of corticosteroids or other immunosuppressive agents;
current or prior therapy with insulin-like growth factor (IGF) inhibitor (monoclonal or specific kinase inhibitor);
history of solid organ transplant;
other malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer;
active central nervous system disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope National Medical Center	Duarte	California	United States	91010
2	UCLA School Of Medicine Mattel's Children's Hospital At UCLA; Division Of Hematology-Oncology	Los Angeles	California	United States	90095-1752
3	Sarcoma Oncology Center	Santa Monica	California	United States	90403
4	Stanford Comprehensive Cancer Center	Stanford	California	United States	94305
5	Washington Cancer Institute; Washington Hospital Center	Washington	District of Columbia	United States	20010
6	Kootenai Medical Center	Coeur d'Alene	Idaho	United States	83814
7	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
8	NIH/NCI	Bethesda	Maryland	United States	20892
9	Massachusetts General Hospital; Dana Farber Partnes Cancer Center	Boston	Massachusetts	United States	02114
10	Dana Farber Partners Can Ctr	Boston	Massachusetts	United States	02115-6084
11	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109
12	Nebraska Methodist Hospital; Onc Hem West	Omaha	Nebraska	United States	68114
13	Albert Einstein College of Medical Pediatrics; Department of Pediatrics	Bronx	New York	United States	10467
14	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
15	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
16	Carolinas Hematology Oncology Associates; Investigational Drug Services - Pharmacy	Charlotte	North Carolina	United States	28203
17	Oregon Health and Science University Cancer Institute	Portland	Oregon	United States	97239
18	Pennsylvania Oncology Hema Asc	Philadelphia	Pennsylvania	United States	19106
19	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
20	Texas Children's Cancer Center; Baylor College of Medicine	Houston	Texas	United States	77030
21	University of Texas M.D. Anderson Cancer Center	Houston	Texas	United States	77030
22	Huntsman Cancer Institute; Orthopedic Center	Salt Lake City	Utah	United States	84112
23	Peter Maccallum Cancer Institute; Medical Oncology	Melbourne	Victoria	Australia	3000
24	BCCA-Vancouver Cancer Centre	Vancouver	British Columbia	Canada	V5Z 4E6
25	Institut Bergonie; Oncologie	Bordeaux		France	33076
26	Centre Oscar Lambret; Chir Cancerologie General	Lille		France	59000
27	Centre Leon Berard; Departement Oncologie Medicale	Lyon		France	69373
28	Institut Curie; Oncologie Medicale	Paris		France	75231
29	Institut Gustave Roussy; Service Pediatrique	Villejuif		France	94805
30	HELIOS Klinikum Bad Saarow; Klinik für Innere Medizin III	Bad Saarow		Germany	15526
31	Uniklinik Mannheim; Sektion Chirurgische Onkologie & Thoraxchirurgie	Mannheim		Germany	68167
32	University Hospital Tübingen	Tübingen		Germany	72076
33	Istituti Ortopedici Rizzoli	Bologna	Emilia-Romagna	Italy	40136
34	Istituto Nazionale Tumori, Sarcoma Unit	Milano	Lombardia	Italy	20133
35	Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology	Rotterdam		Netherlands	3015 CE
36	Norwegian Radium Hospital	Oslo		Norway	0310
37	Hospital Sant Joan De Deu	Esplugues De Llobregas	Barcelona	Spain	08950
38	Skånes University Hospital, Skånes Department of Onclology	Lund		Sweden	221 85
39	UCL Hospital NHS Trust	London		United Kingdom	NW1 2PG
40	Royal Marsden Hospital; Dept of Med-Onc	London		United Kingdom	SW3 6JJ
41	Christie Hospital NHS Trust	Manchester		United Kingdom	M20 4BX

Sponsors and Collaborators

Hoffmann-La Roche
Sarcoma Alliance for Research through Collaboration

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00642941

Other Study ID Numbers:

NO21157
SARC011
2007-003940-30
NCT00615680

First Posted:

Mar 25, 2008

Last Update Posted:

Feb 3, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Sarcoma

Study Results

Participant Flow

Recruitment Details	A screening period was included prior to administration of study drug. Tumor scans/X-rays were to be obtained within 4 weeks, fluro-D-glucose positron emission tomography (FDG-PET) scans within 2 weeks, and Baseline laboratory evaluations within 1 week before first dose.
Pre-assignment Detail

Arm/Group Title	Cohort 1: Ewings Sarcoma Primary Cohort	Cohort 2: Ewings Sarcoma Secondary Cohort	Cohort 3: Ewings Sarcoma Expanded Cohort	Cohort 4: Osteosarcoma	Cohort 5: Synovial Sarcoma	Cohort 6: Rhabdomyosarcoma	Cohort 7a: Alveolar Soft Part Sarcoma	Cohort 7b: Desmoplastic Small Round Cell Tumors.	Cohort 7c: Extraskeletal Myxoid Chondrosarcoma	Cohort 7d: Clear Cell Sarcoma	Cohort 7e: Myxoid Liposarcoma	Cohort 8: Diagnosis Not Specified
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.	Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Period Title: Overall Study
STARTED	70	54	7	40	25	41	23	14	11	9	12	11
COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	70	54	7	40	25	41	23	14	11	9	12	11

Baseline Characteristics

Arm/Group Title	Cohort 1: Ewings Sarcoma Primary Cohort	Cohort 2: Ewings Sarcoma Secondary Cohort	Cohort 3: Ewings Sarcoma Expanded Cohort	Cohort 4: Osteosarcoma	Cohort 5: Synovial Sarcoma	Cohort 6: Rhabdomyosarcoma	Cohort 7a: Alveolar Soft Part Sarcoma	Cohort 7b: Desmoplastic Small Round Cell Tumors.	Cohort 7c: Extraskeletal Myxoid Chondrosarcoma	Cohort 7d: Clear Cell Sarcoma	Cohort 7e: Myxoid Liposarcoma	Cohort 8: Diagnosis Not Specified	Total
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.	Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.	Total of all reporting groups
Overall Participants	70	54	7	40	25	41	23	14	11	9	12	11	317
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	27 (10.72)	28.3 (12.9)	13.3 (3.15)	33.8 (18.83)	41.7 (16.11)	26.5 (12.21)	31.7 (13.67)	23.1 (6.09)	60.9 (11.27)	26.9 (11.01)	50.6 (11.06)	30.7 (18.56)	31.2 (13.36)
Sex: Female, Male (Count of Participants)
Female	20 28.6%	22 40.7%	3 42.9%	20 50%	11 44%	18 43.9%	12 52.2%	1 7.1%	3 27.3%	2 22.2%	3 25%	3 27.3%	118 37.2%
Male	50 71.4%	32 59.3%	4 57.1%	20 50%	14 56%	23 56.1%	11 47.8%	13 92.9%	8 72.7%	7 77.8%	9 75%	8 72.7%	199 62.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8
Description	Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is >=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive.
Time Frame	Baseline up to 6 years (assessed at baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression)

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 due to no efficacy data being collected for that cohort.

Arm/Group Title	Cohort 2: Ewings Sarcoma Secondary Cohort	Cohort 3: Ewings Sarcoma Expanded Cohort	Cohort 4: Osteosarcoma	Cohort 5: Synovial Sarcoma	Cohort 6: Rhabdomyosarcoma	Cohort 7a: Alveolar Soft Part Sarcoma	Cohort 7b: Desmoplastic Small Round Cell Tumors.	Cohort 7c: Extraskeletal Myxoid Chondrosarcoma	Cohort 7d: Clear Cell Sarcoma	Cohort 7e: Myxoid Liposarcoma	Cohort 8: Diagnosis Not Specified
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.	Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Measure Participants	54	0	40	25	41	23	14	11	9	12	11
Number [Percentage of Participants]	11.11 15.9%	2.5 4.6%	4.0 57.1%	4.88 12.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Progression-Free Survival (PFS) Rate According to WHO Response Criteria at 18 Weeks From Start of R2607 Treatment in Cohort 1
Description	The PFS survival rate is a landmark analysis of progression-free survival at 18 weeks from start of treatment. Progression-free survival rate at 18 weeks is a dichotomous endpoint, with a patient categorized as alive (with either stable disease or objective response) at 18 weeks from start of treatment.
Time Frame	Baseline up to 18 weeks (assessed at baseline, every 6 weeks until disease progression)

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment.

Arm/Group Title	Cohort 1: Ewings Sarcoma Primary Cohort
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
Measure Participants	70
Number [Percentage of Participants]	15.81 22.6%

3. Primary Outcome

Title	Percentage of Participants With Adverse Events (AEs) in Cohort 1 and 2
Description
Time Frame	Baseline up to 6 years

Outcome Measure Data

Analysis Population Description
Safety Population: All participants who received at least one dose of study drug at had at least one safety follow-up assessment.

Arm/Group Title	Cohort 1: Ewings Sarcoma Primary Cohort	Cohort 2: Ewings Sarcoma Secondary Cohort
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.
Measure Participants	70	54
Number [percentage of participants]	96 137.1%	96 177.8%

4. Secondary Outcome

Title	Percentage of Participants With Complete or Partial Response According to WHO Response Criteria in Cohort 1
Description	Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is >=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive.
Time Frame	Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment.

Arm/Group Title	Cohort 1: Ewings Sarcoma Primary Cohort
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.
Measure Participants	70
Number [percentage of participants]	8.57 12.2%

5. Secondary Outcome

Title	PFS Rate According to WHO Response Criteria at 18 Weeks From Start of R1507 Treatment in Cohorts 2 to 8
Description	The PFS survival rate is a landmark analysis of progression-free survival at 18 weeks from start of treatment. Progression-free survival rate at 18 weeks is a dichotomous endpoint, with a patient categorized as alive (with either stable disease or objective response at 18 weeks) from start of treatment.
Time Frame	Baseline, every 6 weeks until disease progression (up to 18 weeks)

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 due to no efficacy data being collected for that cohort.

Arm/Group Title	Cohort 2: Ewings Sarcoma Secondary Cohort	Cohort 3: Ewings Sarcoma Expanded Cohort	Cohort 4: Osteosarcoma	Cohort 5: Synovial Sarcoma	Cohort 6: Rhabdomyosarcoma	Cohort 7a: Alveolar Soft Part Sarcoma	Cohort 7b: Desmoplastic Small Round Cell Tumors.	Cohort 7c: Extraskeletal Myxoid Chondrosarcoma	Cohort 7e: Myxoid Liposarcoma	Cohort 7d: Clear Cell Sarcoma	Cohort 8: Diagnosis Not Specified
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.	Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Measure Participants	54	0	40	25	41	23	14	11	9	12	11
Number [Percentage of Participants]	17.16 24.5%	19.69 36.5%	4.00 57.1%	7.32 18.3%	45.40 181.6%	8.16 19.9%	62.34 271%	0 0%	8.33 75.7%	22.86 254%

6. Secondary Outcome

Title	Percentage of Participants With AEs in Cohorts 3-8
Description
Time Frame	Baseline up to 6 years

Outcome Measure Data

Analysis Population Description
Safety Population: All participants who received at least one dose of study drug at had at least one safety follow-up assessment.

Arm/Group Title	Cohort 3: Ewings Sarcoma Expanded Cohort	Cohort 4: Osteosarcoma	Cohort 5: Synovial Sarcoma	Cohort 6: Rhabdomyosarcoma	Cohort 7a: Alveolar Soft Part Sarcoma	Cohort 7b: Desmoplastic Small Round Cell Tumors.	Cohort 7c: Extraskeletal Myxoid Chondrosarcoma	Cohort 7d: Clear Cell Sarcoma	Cohort 7e: Myxoid Liposarcoma	Cohort 8: Diagnosis Not Specified
Arm/Group Description	Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Measure Participants	7	40	25	41	23	14	11	9	12	11
Number [percentage of participants]	85.7 122.4%	100 185.2%	100 1428.6%	95 237.5%	91 364%	86 209.8%	100 434.8%	100 714.3%	100 909.1%	100 1111.1%

7. Secondary Outcome

Title	Duration of Response (DOR) According to WHO Response Criteria in Cohorts 1 to 8
Description	The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is >=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive.
Time Frame	Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3, 7 and 8 due to no DOR data being collected for these cohorts.

Arm/Group Title	Cohort 1: Ewings Sarcoma Primary Cohort	Cohort 2: Ewings Sarcoma Secondary Cohort	Cohort 3: Ewings Sarcoma Expanded Cohort	Cohort 4: Osteosarcoma	Cohort 5: Synovial Sarcoma	Cohort 6: Rhabdomyosarcoma	Cohort 7a: Alveolar Soft Part Sarcoma	Cohort 7b: Desmoplastic Small Round Cell Tumors.	Cohort 7c: Extraskeletal Myxoid Chondrosarcoma	Cohort 7d: Clear Cell Sarcoma	Cohort 7e: Myxoid Liposarcoma	Cohort 8: Diagnosis Not Specified
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.	Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Measure Participants	70	54	0	40	25	41	0	0	0	0	0	0
Median (95% Confidence Interval) [weeks]	44.29	42.86	NA	13.14	NA

8. Secondary Outcome

Title	Time to Progression (TTP) According to WHO Response Criteria in Cohorts 1 to 8
Description	TTP is defined as the time from date of randomization until objective tumor progression. According to the WHO Response Criteria, objective tumor progression is > 25% increase in the area of one or more measurable lesions or the appearance of new lesions.
Time Frame	Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 due to no efficacy data being collected for that cohort.

Arm/Group Title	Cohort 1: Ewings Sarcoma Primary Cohort	Cohort 2: Ewings Sarcoma Secondary Cohort	Cohort 3: Ewings Sarcoma Expanded Cohort	Cohort 4: Osteosarcoma	Cohort 5: Synovial Sarcoma	Cohort 6: Rhabdomyosarcoma	Cohort 7a: Alveolar Soft Part Sarcoma	Cohort 7b: Desmoplastic Small Round Cell Tumors.	Cohort 7c: Extraskeletal Myxoid Chondrosarcoma	Cohort 7d: Clear Cell Sarcoma	Cohort 7e: Myxoid Liposarcoma	Cohort 8: Diagnosis Not Specified
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.	Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Measure Participants	70	54	0	40	25	41	23	14	11	9	12	11
Median (95% Confidence Interval) [weeks]	6.00	6.00	5.71	6.00	5.50	11.14	6.14	18.00	5.57	5.86	6.14

9. Secondary Outcome

Title	Failure-Free Survival (FFS) According to WHO Response Criteria in Cohorts 1 to 8
Description	FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause.
Time Frame	Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)

Outcome Measure Data

Analysis Population Description
Data was not collected for this endpoint.

Arm/Group Title	Cohort 1: Ewings Sarcoma Primary Cohort	Cohort 2: Ewings Sarcoma Secondary Cohort	Cohort 3: Ewings Sarcoma Expanded Cohort	Cohort 4: Osteosarcoma	Cohort 5: Synovial Sarcoma	Cohort 6: Rhabdomyosarcoma	Cohort 7a: Alveolar Soft Part Sarcoma	Cohort 7b: Desmoplastic Small Round Cell Tumors.	Cohort 7c: Extraskeletal Myxoid Chondrosarcoma	Cohort 7d: Clear Cell Sarcoma	Cohort 7e: Myxoid Liposarcoma	Cohort 8: Diagnosis Not Specified
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.	Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Measure Participants	0	0	0	0	0	0	0	0	0	0	0	0

10. Secondary Outcome

Title	Overall Survival (OS) in Cohorts 1 to 8
Description	OS was measured from the time of study registration to the date of death or was censored at the date of last contact.
Time Frame	Baseline until death (up to 6 years)

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 and 7c due to no overall survival data being collected for those cohorts.

Arm/Group Title	Cohort 1: Ewings Sarcoma Primary Cohort	Cohort 2: Ewings Sarcoma Secondary Cohort	Cohort 3: Ewings Sarcoma Expanded Cohort	Cohort 4: Osteosarcoma	Cohort 5: Synovial Sarcoma	Cohort 6: Rhabdomyosarcoma	Cohort 7a: Alveolar Soft Part Sarcoma	Cohort 7b: Desmoplastic Small Round Cell Tumors.	Cohort 7c: Extraskeletal Myxoid Chondrosarcoma	Cohort 7d: Clear Cell Sarcoma	Cohort 7e: Myxoid Liposarcoma	Cohort 8: Diagnosis Not Specified
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.	Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Measure Participants	70	54	0	40	25	61	23	14	11	9	12	11
Median (95% Confidence Interval) [weeks]	29.57	43.57	37.14	40.71	30.86	42.43	40.86	NA	17.00	36.00	17.43

11. Secondary Outcome

Title	PFS According to WHO Response Criteria in Cohorts 1 to 8
Description	PFS is defined as the duration of time from start of treatment to time of objective progression or death.
Time Frame	Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years)

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 due to no efficacy data being collected for that cohort.

Arm/Group Title	Cohort 1: Ewings Sarcoma Primary Cohort	Cohort 2: Ewings Sarcoma Secondary Cohort	Cohort 3: Ewings Sarcoma Expanded Cohort	Cohort 4: Osteosarcoma	Cohort 5: Synovial Sarcoma	Cohort 6: Rhabdomyosarcoma	Cohort 7a: Alveolar Soft Part Sarcoma	Cohort 7b: Desmoplastic Small Round Cell Tumors.	Cohort 7c: Extraskeletal Myxoid Chondrosarcoma	Cohort 7d: Clear Cell Sarcoma	Cohort 7e: Myxoid Liposarcoma	Cohort 8: Diagnosis Not Specified
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.	Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Measure Participants	70	54	0	40	25	41	23	14	11	9	12	11
Median (95% Confidence Interval) [weeks]	6.00	6.00	5.71	6.00	5.43	11.14	6.14	18.00	5.57	5.86	6.14

12. Secondary Outcome

Title	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of R1507
Description
Time Frame	Predose (0 hours [h]), end of 60-90 minutes infusion (EOI), postdose (2, 24, 72-96 h) in Week 1; predose (0 h) and EOI in Weeks 2, 4, 6, 9; predose (0 h), EOI, postdose (48 h) in Week 12; predose (0 h) in Week 13, at final visit (up to 6 years)

Outcome Measure Data

Analysis Population Description
Data was not collected for this pharmacokinetic endpoint.

Arm/Group Title	Cohort 1: Ewings Sarcoma Primary Cohort	Cohort 2: Ewings Sarcoma Secondary Cohort	Cohort 3: Ewings Sarcoma Expanded Cohort	Cohort 4: Osteosarcoma	Cohort 5: Synovial Sarcoma	Cohort 6: Rhabdomyosarcoma	Cohort 7a: Alveolar Soft Part Sarcoma	Cohort 7b: Desmoplastic Small Round Cell Tumors.	Cohort 7c: Extraskeletal Myxoid Chondrosarcoma	Cohort 7d: Clear Cell Sarcoma	Cohort 7e: Myxoid Liposarcoma	Cohort 8: Diagnosis Not Specified
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.	Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Measure Participants	0	0	0	0	0	0	0	0	0	0	0	0

13. Secondary Outcome

Title	Pharmacokinetics: Clearance (CL) of R1507
Description
Time Frame	Predose (0 h), EOI (infusion over 60-90 minutes), postdose (2, 24, 72-96 h) in Week 1; predose (0 h) and EOI in Weeks 2, 4, 6, 9; predose (0 h), EOI, postdose (48 h) in Week 12; predose (0 h) in Week 13, at final visit (up to 6 years)

Outcome Measure Data

Analysis Population Description
Data was not collected for this pharmacokinetic endpoint.

Arm/Group Title	Cohort 1: Ewings Sarcoma Primary Cohort	Cohort 2: Ewings Sarcoma Secondary Cohort	Cohort 3: Ewings Sarcoma Expanded Cohort	Cohort 4: Osteosarcoma	Cohort 5: Synovial Sarcoma	Cohort 6: Rhabdomyosarcoma	Cohort 7a: Alveolar Soft Part Sarcoma	Cohort 7b: Desmoplastic Small Round Cell Tumors.	Cohort 7c: Extraskeletal Myxoid Chondrosarcoma	Cohort 7d: Clear Cell Sarcoma	Cohort 7e: Myxoid Liposarcoma	Cohort 8: Diagnosis Not Specified
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.	Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
Measure Participants	0	0	0	0	0	0	0	0	0	0	0	0

Adverse Events

	Cohort 1: Ewings Sarcoma Primary Cohort		Cohort 2: Ewings Sarcoma Secondary Cohort		Cohort 3: Ewings Sarcoma Expanded Cohort		Cohort 4: Osteosarcoma		Cohort 5: Synovial Sarcoma		Cohort 6: Rhabdomyosarcoma		Cohort 7a: Alveolar Soft Part Sarcoma		Cohort 7b: Desmoplastic Small Round Cell Tumors		Cohort 7c: Extraskeletal Myxoid Chondrosarcoma		Cohort 7d: Clear Cell Sarcoma		Cohort 7e: Myxoid Liposarcoma		Cohort 8: Diagnosis Not Specified
Time Frame	Baseline up to 6 years
Adverse Event Reporting Description	Safety Population: All participants who received at least one dose of study drug at had at least one safety follow-up assessment.

Arm/Group Title	Cohort 1: Ewings Sarcoma Primary Cohort		Cohort 2: Ewings Sarcoma Secondary Cohort		Cohort 3: Ewings Sarcoma Expanded Cohort		Cohort 4: Osteosarcoma		Cohort 5: Synovial Sarcoma		Cohort 6: Rhabdomyosarcoma		Cohort 7a: Alveolar Soft Part Sarcoma		Cohort 7b: Desmoplastic Small Round Cell Tumors		Cohort 7c: Extraskeletal Myxoid Chondrosarcoma		Cohort 7d: Clear Cell Sarcoma		Cohort 7e: Myxoid Liposarcoma		Cohort 8: Diagnosis Not Specified
Arm/Group Description	Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 1 includes individuals with Ewing's sarcoma who have relapsed within 24 weeks after diagnosis and have received two or more prior chemotherapy regimens.		Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 2 includes individuals with Ewing's sarcoma who have relapsed more than 24 weeks after diagnosis and have only received one prior chemotherapy regimen.		Participants 2 to 21 years of age with recurrent or refractory sarcoma receive R1507 as 27 mg/kg via IV infusion every 3 weeks until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 3 includes individuals with Ewing's sarcoma who were enrolled and treated following safety evaluation in other cohorts.		Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 4 includes individuals with osteosarcoma.		Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 5 includes individuals with synovial sarcoma.		Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 6 includes individuals with rhabdomyosarcoma.		Participants 2 years of age and older with recurrent or refractory sarcoma received R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7a included individuals with alveolar soft part sarcoma.		Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7b includes individuals with desmoplastic small round cell tumors.		Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7c includes individuals with extraskeletal myxoid chondrosarcoma.		Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7d includes individuals with clear cell sarcoma.		Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 7e includes individuals with myxoid liposarcoma.		Participants 2 years of age and older with recurrent or refractory sarcoma receive R1507 as 9 mg/kg via IV infusion once weekly until disease progression, intercurrent illness, unacceptable toxicity, prolonged (2-week) time off treatment, withdrawal, loss to follow-up, investigator decision, or death. Cohort 8 includes individuals with subtypes of sarcoma not specified in the protocol.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/70 (12.9%)		5/54 (9.3%)		2/7 (28.6%)		7/40 (17.5%)		3/25 (12%)		3/41 (7.3%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		1/12 (8.3%)		2/11 (18.2%)
Serious Adverse Events
	Cohort 1: Ewings Sarcoma Primary Cohort		Cohort 2: Ewings Sarcoma Secondary Cohort		Cohort 3: Ewings Sarcoma Expanded Cohort		Cohort 4: Osteosarcoma		Cohort 5: Synovial Sarcoma		Cohort 6: Rhabdomyosarcoma		Cohort 7a: Alveolar Soft Part Sarcoma		Cohort 7b: Desmoplastic Small Round Cell Tumors		Cohort 7c: Extraskeletal Myxoid Chondrosarcoma		Cohort 7d: Clear Cell Sarcoma		Cohort 7e: Myxoid Liposarcoma		Cohort 8: Diagnosis Not Specified
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/70 (15.7%)		13/54 (24.1%)		1/7 (14.3%)		4/40 (10%)		5/25 (20%)		4/41 (9.8%)		1/23 (4.3%)		1/14 (7.1%)		0/11 (0%)		3/9 (33.3%)		2/12 (16.7%)		4/11 (36.4%)
Blood and lymphatic system disorders
Thrombocytopenia	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Endocrine disorders
Adrenal haemorrhage	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Gastrointestinal disorders
Constipation	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Intestinal perforation	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Nausea	0/70 (0%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Obstruction gastric	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Upper gastrointestinal haemorrhage	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Vomiting	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
General disorders
Fatigue	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Inflammation	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Oedema peripheral	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Pain	1/70 (1.4%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Pyrexia	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Infections and infestations
Pneumonia	2/70 (2.9%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Bacteraemia	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Cellulitis	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Device related infection	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Escherichia sepsis	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Infection	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Pyelonephritis	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Sepsis	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Staphylococcal infection	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Urinary tract infection	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Injury, poisoning and procedural complications
Spinal compression fracture	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Metabolism and nutrition disorders
Dehydration	0/70 (0%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Hyperglycaemia	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Hyponatraemia	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Flank pain	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Neck pain	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Pain in extremity	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage	0/70 (0%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Nervous system disorders
Facial palsy	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Somnolence	2/70 (2.9%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Psychiatric disorders
Mental status changes	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Renal and urinary disorders
Hydronephrosis	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Dyspnoea	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Hypoxia	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Pleural effusion	0/70 (0%)		0/54 (0%)		1/7 (14.3%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Pneumothorax	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Pulmonary embolism	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Respiratory failure	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Vascular disorders
Deep vein thrombosis	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Haemorrhage	0/70 (0%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Orthostatic hypotension	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Thrombosis	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Cohort 1: Ewings Sarcoma Primary Cohort		Cohort 2: Ewings Sarcoma Secondary Cohort		Cohort 3: Ewings Sarcoma Expanded Cohort		Cohort 4: Osteosarcoma		Cohort 5: Synovial Sarcoma		Cohort 6: Rhabdomyosarcoma		Cohort 7a: Alveolar Soft Part Sarcoma		Cohort 7b: Desmoplastic Small Round Cell Tumors		Cohort 7c: Extraskeletal Myxoid Chondrosarcoma		Cohort 7d: Clear Cell Sarcoma		Cohort 7e: Myxoid Liposarcoma		Cohort 8: Diagnosis Not Specified
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	67/70 (95.7%)		52/54 (96.3%)		6/7 (85.7%)		40/40 (100%)		25/25 (100%)		39/41 (95.1%)		21/23 (91.3%)		12/14 (85.7%)		11/11 (100%)		9/9 (100%)		12/12 (100%)		11/11 (100%)
Blood and lymphatic system disorders
Anaemia	8/70 (11.4%)		5/54 (9.3%)		0/7 (0%)		4/40 (10%)		1/25 (4%)		3/41 (7.3%)		2/23 (8.7%)		1/14 (7.1%)		0/11 (0%)		2/9 (22.2%)		2/12 (16.7%)		3/11 (27.3%)
Thrombocytopenia	9/70 (12.9%)		4/54 (7.4%)		0/7 (0%)		3/40 (7.5%)		0/25 (0%)		2/41 (4.9%)		0/23 (0%)		2/14 (14.3%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Neutropenia	2/70 (2.9%)		2/54 (3.7%)		0/7 (0%)		2/40 (5%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Leukopenia	3/70 (4.3%)		0/54 (0%)		0/7 (0%)		5/40 (12.5%)		0/25 (0%)		0/41 (0%)		2/23 (8.7%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Haemoglobinaemia	5/70 (7.1%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Lymphopenia	2/70 (2.9%)		0/54 (0%)		0/7 (0%)		4/40 (10%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Leukocytosis	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Lymphadenopathy	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		1/11 (9.1%)
Cardiac disorders
Tachycardia	0/70 (0%)		3/54 (5.6%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		2/23 (8.7%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Pericardia effusion	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Sinus tachycardia	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Palpitations	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Pericarditis	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Ear and labyrinth disorders
Ear pain	3/70 (4.3%)		1/54 (1.9%)		0/7 (0%)		2/40 (5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Tinnitus	2/70 (2.9%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Ear discomfort	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		2/40 (5%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Eye disorders
Vision blurred	1/70 (1.4%)		2/54 (3.7%)		0/7 (0%)		2/40 (5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Visual impairment	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		2/23 (8.7%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Diplopia	1/70 (1.4%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Dry eye	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		1/23 (4.3%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Ocular hyperaemia	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Gastrointestinal disorders
Abdominal pain	4/70 (5.7%)		2/54 (3.7%)		0/7 (0%)		2/40 (5%)		2/25 (8%)		4/41 (9.8%)		1/23 (4.3%)		3/14 (21.4%)		0/11 (0%)		2/9 (22.2%)		1/12 (8.3%)		0/11 (0%)
Constipation	12/70 (17.1%)		10/54 (18.5%)		0/7 (0%)		7/40 (17.5%)		2/25 (8%)		3/41 (7.3%)		3/23 (13%)		3/14 (21.4%)		3/11 (27.3%)		3/9 (33.3%)		2/12 (16.7%)		1/11 (9.1%)
Diarrhoea	11/70 (15.7%)		15/54 (27.8%)		0/7 (0%)		8/40 (20%)		3/25 (12%)		6/41 (14.6%)		7/23 (30.4%)		1/14 (7.1%)		3/11 (27.3%)		0/9 (0%)		2/12 (16.7%)		0/11 (0%)
Nausea	9/70 (12.9%)		20/54 (37%)		0/7 (0%)		7/40 (17.5%)		5/25 (20%)		10/41 (24.4%)		6/23 (26.1%)		1/14 (7.1%)		2/11 (18.2%)		4/9 (44.4%)		3/12 (25%)		3/11 (27.3%)
Vomiting	11/70 (15.7%)		11/54 (20.4%)		0/7 (0%)		8/40 (20%)		4/25 (16%)		8/41 (19.5%)		6/23 (26.1%)		0/14 (0%)		1/11 (9.1%)		2/9 (22.2%)		1/12 (8.3%)		3/11 (27.3%)
Abdominal pain upper	6/70 (8.6%)		4/54 (7.4%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Dyspepsia	2/70 (2.9%)		3/54 (5.6%)		0/7 (0%)		3/40 (7.5%)		1/25 (4%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		2/11 (18.2%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Haemorrhoids	2/70 (2.9%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		1/41 (2.4%)		1/23 (4.3%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Stomatitis	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		1/41 (2.4%)		2/23 (8.7%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Dry mouth	2/70 (2.9%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Dysphagia	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Flatulence	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		2/41 (4.9%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Abdominal distension	0/70 (0%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Faecal incontinence	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Gastrooesophageal reflux disease	0/70 (0%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Gastritis	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Haematochezia	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Toothache	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Ascites	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Gastrointestinal haemorrhage	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Gastrointestinal motility disorder	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Gingival pain	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Proctitis	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
General disorders
Asthenia	5/70 (7.1%)		9/54 (16.7%)		0/7 (0%)		4/40 (10%)		0/25 (0%)		2/41 (4.9%)		2/23 (8.7%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		4/11 (36.4%)
Chest pain	7/70 (10%)		7/54 (13%)		0/7 (0%)		6/40 (15%)		3/25 (12%)		2/41 (4.9%)		3/23 (13%)		1/14 (7.1%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Fatigue	19/70 (27.1%)		22/54 (40.7%)		1/7 (14.3%)		13/40 (32.5%)		3/25 (12%)		14/41 (34.1%)		5/23 (21.7%)		5/14 (35.7%)		5/11 (45.5%)		5/9 (55.6%)		5/12 (41.7%)		3/11 (27.3%)
Infusion related reaction	5/70 (7.1%)		3/54 (5.6%)		0/7 (0%)		4/40 (10%)		2/25 (8%)		3/41 (7.3%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Pain	11/70 (15.7%)		6/54 (11.1%)		1/7 (14.3%)		1/40 (2.5%)		0/25 (0%)		4/41 (9.8%)		1/23 (4.3%)		2/14 (14.3%)		0/11 (0%)		2/9 (22.2%)		0/12 (0%)		0/11 (0%)
Pyrexia	10/70 (14.3%)		13/54 (24.1%)		0/7 (0%)		3/40 (7.5%)		3/25 (12%)		0/41 (0%)		6/23 (26.1%)		2/14 (14.3%)		0/11 (0%)		2/9 (22.2%)		1/12 (8.3%)		0/11 (0%)
Oedema peripheral	3/70 (4.3%)		1/54 (1.9%)		0/7 (0%)		3/40 (7.5%)		3/25 (12%)		0/41 (0%)		2/23 (8.7%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		3/12 (25%)		2/11 (18.2%)
Oedema	4/70 (5.7%)		1/54 (1.9%)		0/7 (0%)		2/40 (5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Chills	2/70 (2.9%)		0/54 (0%)		0/7 (0%)		2/40 (5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Chest discomfort	1/70 (1.4%)		2/54 (3.7%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Ulcer	0/70 (0%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		2/9 (22.2%)		0/12 (0%)		0/11 (0%)
Hyperthermia	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Thirst	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Hepatobiliary disorders
Hyperbilirubinaemia	3/70 (4.3%)		3/54 (5.6%)		1/7 (14.3%)		0/40 (0%)		2/25 (8%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Liver disorder	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Infections and infestations
Upper respiratory tract infection	0/70 (0%)		4/54 (7.4%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		2/23 (8.7%)		1/14 (7.1%)		1/11 (9.1%)		1/9 (11.1%)		2/12 (16.7%)		0/11 (0%)
Urinary tract infection	0/70 (0%)		6/54 (11.1%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		2/41 (4.9%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Nasopharyngitis	1/70 (1.4%)		3/54 (5.6%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		1/41 (2.4%)		1/23 (4.3%)		0/14 (0%)		2/11 (18.2%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Lower respiratory tract infection	0/70 (0%)		3/54 (5.6%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Cellulitis	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Influenza	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Pharyngitis	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		2/41 (4.9%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Borrelia infection	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Furuncle	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Rash pustular	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Respiratory tract infection	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Viral infection	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Injury, poisoning and procedural complications
Contusion	0/70 (0%)		4/54 (7.4%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Procedural pain	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Foreign body	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Wound	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Joint sprain	0/70 (0%)		0/54 (0%)		1/7 (14.3%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Investigations
Alanine aminotransferase increased	5/70 (7.1%)		2/54 (3.7%)		1/7 (14.3%)		2/40 (5%)		3/25 (12%)		7/41 (17.1%)		2/23 (8.7%)		2/14 (14.3%)		0/11 (0%)		0/9 (0%)		2/12 (16.7%)		0/11 (0%)
Aspartate aminotransferase increased	8/70 (11.4%)		4/54 (7.4%)		1/7 (14.3%)		5/40 (12.5%)		4/25 (16%)		5/41 (12.2%)		1/23 (4.3%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		3/12 (25%)		0/11 (0%)
Blood alkaline phosphatase increased	8/70 (11.4%)		2/54 (3.7%)		0/7 (0%)		5/40 (12.5%)		1/25 (4%)		1/41 (2.4%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		2/9 (22.2%)		1/12 (8.3%)		1/11 (9.1%)
Blood lactate dehydrogenase increased	5/70 (7.1%)		2/54 (3.7%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		3/41 (7.3%)		2/23 (8.7%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		1/12 (8.3%)		2/11 (18.2%)
Weight decreased	8/70 (11.4%)		6/54 (11.1%)		0/7 (0%)		6/40 (15%)		1/25 (4%)		4/41 (9.8%)		4/23 (17.4%)		1/14 (7.1%)		2/11 (18.2%)		2/9 (22.2%)		2/12 (16.7%)		1/11 (9.1%)
Blood creatinine increased	4/70 (5.7%)		3/54 (5.6%)		0/7 (0%)		3/40 (7.5%)		0/25 (0%)		2/41 (4.9%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Neutrophil count decreased	3/70 (4.3%)		3/54 (5.6%)		1/7 (14.3%)		1/40 (2.5%)		2/25 (8%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Blood bilirubin increased	4/70 (5.7%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		1/25 (4%)		1/41 (2.4%)		1/23 (4.3%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Haemoglobin decreased	1/70 (1.4%)		1/54 (1.9%)		0/7 (0%)		1/40 (2.5%)		1/25 (4%)		3/41 (7.3%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Haemoglobin	1/70 (1.4%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		3/9 (33.3%)		0/12 (0%)		0/11 (0%)
White blood cell count decreased	0/70 (0%)		2/54 (3.7%)		2/7 (28.6%)		0/40 (0%)		1/25 (4%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Blood glucose increased	0/70 (0%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		1/25 (4%)		0/41 (0%)		2/23 (8.7%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Transaminases increased	2/70 (2.9%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		2/41 (4.9%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Breath sounds abnormal	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		2/41 (4.9%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Gamma-glutamyltransferase	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		2/9 (22.2%)		0/12 (0%)		0/11 (0%)
Aspartate Aminotransferase	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		2/9 (22.2%)		0/12 (0%)		0/11 (0%)
Blood alkaline phosphatase	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Platelet count	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Alanine aminotransferase	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Blood creatinine	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Carbon dioxide decreased	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Neutrophil count	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
White blood cell count	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Blood creatine phosphokinase	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Haematocrit	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Protein urine present	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Urine bilirubin increased	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Platelet count decreased	2/70 (2.9%)		3/54 (5.6%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Metabolism and nutrition disorders
Decreased appetite	13/70 (18.6%)		12/54 (22.2%)		0/7 (0%)		2/40 (5%)		1/25 (4%)		7/41 (17.1%)		2/23 (8.7%)		2/14 (14.3%)		3/11 (27.3%)		2/9 (22.2%)		1/12 (8.3%)		2/11 (18.2%)
Hyperglycaemia	12/70 (17.1%)		9/54 (16.7%)		0/7 (0%)		5/40 (12.5%)		4/25 (16%)		4/41 (9.8%)		4/23 (17.4%)		3/14 (21.4%)		5/11 (45.5%)		2/9 (22.2%)		0/12 (0%)		0/11 (0%)
Hypoalbuminaemia	6/70 (8.6%)		3/54 (5.6%)		0/7 (0%)		1/40 (2.5%)		1/25 (4%)		1/41 (2.4%)		2/23 (8.7%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		2/12 (16.7%)		1/11 (9.1%)
Hypokalaemia	4/70 (5.7%)		2/54 (3.7%)		1/7 (14.3%)		1/40 (2.5%)		2/25 (8%)		1/41 (2.4%)		4/23 (17.4%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		1/12 (8.3%)		1/11 (9.1%)
Hyponatraemia	6/70 (8.6%)		7/54 (13%)		1/7 (14.3%)		1/40 (2.5%)		2/25 (8%)		0/41 (0%)		2/23 (8.7%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		1/11 (9.1%)
Hypophosphataemia	4/70 (5.7%)		3/54 (5.6%)		1/7 (14.3%)		1/40 (2.5%)		2/25 (8%)		2/41 (4.9%)		5/23 (21.7%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Hypocalcaemia	4/70 (5.7%)		1/54 (1.9%)		0/7 (0%)		1/40 (2.5%)		2/25 (8%)		1/41 (2.4%)		2/23 (8.7%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		2/12 (16.7%)		1/11 (9.1%)
Dehydration	1/70 (1.4%)		2/54 (3.7%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		1/41 (2.4%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		2/9 (22.2%)		1/12 (8.3%)		0/11 (0%)
Hypomagnesaemia	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		2/40 (5%)		2/25 (8%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Hyperkalaemia	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Hypoglycaemia	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		2/40 (5%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Hypermagnesaemia	1/70 (1.4%)		1/54 (1.9%)		1/7 (14.3%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Type 2 diabetes mellitus	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Hypercalcaemia	2/70 (2.9%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		1/41 (2.4%)		2/23 (8.7%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	7/70 (10%)		6/54 (11.1%)		0/7 (0%)		2/40 (5%)		0/25 (0%)		2/41 (4.9%)		2/23 (8.7%)		0/14 (0%)		2/11 (18.2%)		1/9 (11.1%)		1/12 (8.3%)		0/11 (0%)
Back pain	2/70 (2.9%)		4/54 (7.4%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Muscle spasms	7/70 (10%)		8/54 (14.8%)		0/7 (0%)		9/40 (22.5%)		1/25 (4%)		6/41 (14.6%)		4/23 (17.4%)		3/14 (21.4%)		2/11 (18.2%)		2/9 (22.2%)		1/12 (8.3%)		0/11 (0%)
Musculoskeletal pain	4/70 (5.7%)		4/54 (7.4%)		0/7 (0%)		1/40 (2.5%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		2/9 (22.2%)		1/12 (8.3%)		1/11 (9.1%)
Pain in extremity	5/70 (7.1%)		5/54 (9.3%)		0/7 (0%)		5/40 (12.5%)		1/25 (4%)		0/41 (0%)		1/23 (4.3%)		1/14 (7.1%)		1/11 (9.1%)		3/9 (33.3%)		1/12 (8.3%)		2/11 (18.2%)
Musculoskeletal chest pain	4/70 (5.7%)		4/54 (7.4%)		0/7 (0%)		1/40 (2.5%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		2/9 (22.2%)		1/12 (8.3%)		1/11 (9.1%)
Myalgia	5/70 (7.1%)		3/54 (5.6%)		0/7 (0%)		1/40 (2.5%)		1/25 (4%)		0/41 (0%)		1/23 (4.3%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Groin pain	2/70 (2.9%)		3/54 (5.6%)		0/7 (0%)		2/40 (5%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Muscular weakness	4/70 (5.7%)		3/54 (5.6%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Bone pain	2/70 (2.9%)		4/54 (7.4%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Flank pain	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		1/40 (2.5%)		2/25 (8%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Neck pain	0/70 (0%)		2/54 (3.7%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Muscle twitching	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Pain in jaw	0/70 (0%)		1/54 (1.9%)		1/7 (14.3%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain	2/70 (2.9%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		2/41 (4.9%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Nervous system disorders
Headache	10/70 (14.3%)		17/54 (31.5%)		0/7 (0%)		4/40 (10%)		0/25 (0%)		7/41 (17.1%)		5/23 (21.7%)		3/14 (21.4%)		1/11 (9.1%)		1/9 (11.1%)		1/12 (8.3%)		4/11 (36.4%)
Paraesthesia	0/70 (0%)		2/54 (3.7%)		0/7 (0%)		2/40 (5%)		0/25 (0%)		2/41 (4.9%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		2/12 (16.7%)		1/11 (9.1%)
Dizziness	1/70 (1.4%)		2/54 (3.7%)		0/7 (0%)		2/40 (5%)		2/25 (8%)		3/41 (7.3%)		2/23 (8.7%)		0/14 (0%)		1/11 (9.1%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Somnolence	4/70 (5.7%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		2/41 (4.9%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Neuropathy peripheral	3/70 (4.3%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Peripheral sensory neuropathy	0/70 (0%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Dysarthria	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Dysgeusia	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Hemiparesis	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Syncope	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Cerebral ischaemia	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Depressed level of consciousness	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Psychiatric disorders
Anxiety	4/70 (5.7%)		1/54 (1.9%)		0/7 (0%)		5/40 (12.5%)		3/25 (12%)		4/41 (9.8%)		0/23 (0%)		3/14 (21.4%)		0/11 (0%)		1/9 (11.1%)		1/12 (8.3%)		0/11 (0%)
Insomnia	2/70 (2.9%)		4/54 (7.4%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		3/41 (7.3%)		2/23 (8.7%)		1/14 (7.1%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		1/11 (9.1%)
Depression	1/70 (1.4%)		5/54 (9.3%)		0/7 (0%)		3/40 (7.5%)		2/25 (8%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Mental status changes	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Agitation	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Decreased activity	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Delirium	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Renal and urinary disorders
Haematuria	2/70 (2.9%)		2/54 (3.7%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		3/41 (7.3%)		1/23 (4.3%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Dysuria	0/70 (0%)		3/54 (5.6%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Urinary retention	1/70 (1.4%)		1/54 (1.9%)		1/7 (14.3%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Renal failure acute	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		2/9 (22.2%)		0/12 (0%)		0/11 (0%)
Pollakiuria	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Urinary incontinence	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Chromaturia	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Reproductive system and breast disorders
Vaginal haemorrhage	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Testicular torsion	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	7/70 (10%)		10/54 (18.5%)		0/7 (0%)		9/40 (22.5%)		5/25 (20%)		3/41 (7.3%)		6/23 (26.1%)		0/14 (0%)		6/11 (54.5%)		3/9 (33.3%)		1/12 (8.3%)		1/11 (9.1%)
Dyspnoea	6/70 (8.6%)		13/54 (24.1%)		0/7 (0%)		5/40 (12.5%)		4/25 (16%)		2/41 (4.9%)		1/23 (4.3%)		1/14 (7.1%)		1/11 (9.1%)		2/9 (22.2%)		2/12 (16.7%)		1/11 (9.1%)
Epistaxis	2/70 (2.9%)		5/54 (9.3%)		0/7 (0%)		3/40 (7.5%)		0/25 (0%)		3/41 (7.3%)		4/23 (17.4%)		1/14 (7.1%)		2/11 (18.2%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Oropharyngeal pain	5/70 (7.1%)		6/54 (11.1%)		0/7 (0%)		5/40 (12.5%)		0/25 (0%)		2/41 (4.9%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Haemoptysis	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		1/40 (2.5%)		1/25 (4%)		1/41 (2.4%)		2/23 (8.7%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		2/11 (18.2%)
Pleural effusion	0/70 (0%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		2/25 (8%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		2/12 (16.7%)		0/11 (0%)
Wheezing	2/70 (2.9%)		3/54 (5.6%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Rhinorrhoea	0/70 (0%)		2/54 (3.7%)		0/7 (0%)		2/40 (5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Hypoxia	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Bronchospasm	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		2/11 (18.2%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Pneumothorax	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Respiratory disorder	0/70 (0%)		1/54 (1.9%)		1/7 (14.3%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Dyspnoea exertional	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Pleuritic pain	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		1/14 (7.1%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Rales	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Skin and subcutaneous tissue disorders
Rash	2/70 (2.9%)		6/54 (11.1%)		0/7 (0%)		1/40 (2.5%)		1/25 (4%)		3/41 (7.3%)		1/23 (4.3%)		2/14 (14.3%)		1/11 (9.1%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Pruritus	2/70 (2.9%)		2/54 (3.7%)		0/7 (0%)		2/40 (5%)		0/25 (0%)		2/41 (4.9%)		0/23 (0%)		1/14 (7.1%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Night sweats	3/70 (4.3%)		2/54 (3.7%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Dry skin	1/70 (1.4%)		1/54 (1.9%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		1/14 (7.1%)		2/11 (18.2%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Alopecia	0/70 (0%)		2/54 (3.7%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		2/41 (4.9%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Erythema	0/70 (0%)		0/54 (0%)		0/7 (0%)		1/40 (2.5%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		1/9 (11.1%)		0/12 (0%)		1/11 (9.1%)
Nail disorder	0/70 (0%)		0/54 (0%)		0/7 (0%)		3/40 (7.5%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Acne	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		2/11 (18.2%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Urticaria	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		1/9 (11.1%)		0/12 (0%)		0/11 (0%)
Rash papular	0/70 (0%)		0/54 (0%)		0/7 (0%)		2/40 (5%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Decubitus ulcer	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)
Skin irritation	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Skin lesion	0/70 (0%)		0/54 (0%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		1/11 (9.1%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Vascular disorders
Hypertension	1/70 (1.4%)		1/54 (1.9%)		0/7 (0%)		1/40 (2.5%)		2/25 (8%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		3/11 (27.3%)		0/9 (0%)		2/12 (16.7%)		0/11 (0%)
Hot flush	1/70 (1.4%)		1/54 (1.9%)		0/7 (0%)		3/40 (7.5%)		0/25 (0%)		0/41 (0%)		1/23 (4.3%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		0/11 (0%)
Hypotension	1/70 (1.4%)		0/54 (0%)		0/7 (0%)		2/40 (5%)		1/25 (4%)		0/41 (0%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		1/12 (8.3%)		0/11 (0%)
Haemorrhage	1/70 (1.4%)		1/54 (1.9%)		0/7 (0%)		0/40 (0%)		0/25 (0%)		1/41 (2.4%)		0/23 (0%)		0/14 (0%)		0/11 (0%)		0/9 (0%)		0/12 (0%)		1/11 (9.1%)

Limitations/Caveats

The study was closed to further enrollment due to a decision by the Sponsor to discontinue development of R1507. The decision was made based upon available data from other completed/ongoing trials of R1507 and was not due to safety concerns.

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Certain Agreements

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

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact

Name/Title	Study Director
Organization	F. Hoffmann-La Roche AG
Phone	+41 616878333
Email	global.trial_information@roche.com

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00642941

Other Study ID Numbers:

NO21157
SARC011
2007-003940-30
NCT00615680

First Posted:

Mar 25, 2008

Last Update Posted:

Feb 3, 2021

Last Verified:

Jan 1, 2021

A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

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Certain Agreements

Results Point of Contact