Trial Outcomes & Findings for Mature B-Cell Lymphoma And Leukemia Study III (NCT NCT01046825)

NCT ID: NCT01046825

Last Updated: 2025-12-10

Results Overview

Gene expression levels in BL vs. non-BL will be analyzed through approximately 22,000 probesets on the Affymetrix U133A GeneChip by using two-factor analysis of variance model for each gene.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2/PHASE3
• Target enrollment: 128 participants
• Primary outcome timeframe: 1 year after the participant is enrolled
• Results posted on: 2025-12-10

Participant Flow

115 patients were recruited between 15APR1309Sept2010 and 31AUG2022. One patient died at the same day he was enrolled and did not start any treatment and risk was not determined and was excluded in the treatment outcome analysis. One was found to be ineligible after the start of treatment. Thirteen participants from diverse geographical regions were enrolled in the biology only part of the study and no outcome data is available.

Participant milestones

Measure	Group A Completely resected stage I or completely resected abdominal stage II lesions.	Group B All cases not eligible for Group A or Group C. (Murphy Stage III and non-CNS Stage IV)	Group C Any CNS involvement and/or bone marrow involvement ≥ 25% blasts. For CNS involvement one or more of the following applies: 1. Any L3 blasts in CSF 2. Cranial nerve palsy (if not explained by extracranial tumor) 3. Clinical spinal cord compression 4. Isolated intracerebral mass 5. Parameningeal extension: cranial and/or spinal	Unknown Risk Patient died prior to treatment and risk assignment	Biology Only Participants enrolled on the biology only arm
Overall Study STARTED	5	87	22	1	13
Overall Study COMPLETED	5	84	19	0	0
Overall Study NOT COMPLETED	0	3	3	1	13

Reasons for withdrawal

Measure	Group A Completely resected stage I or completely resected abdominal stage II lesions.	Group B All cases not eligible for Group A or Group C. (Murphy Stage III and non-CNS Stage IV)	Group C Any CNS involvement and/or bone marrow involvement ≥ 25% blasts. For CNS involvement one or more of the following applies: 1. Any L3 blasts in CSF 2. Cranial nerve palsy (if not explained by extracranial tumor) 3. Clinical spinal cord compression 4. Isolated intracerebral mass 5. Parameningeal extension: cranial and/or spinal	Unknown Risk Patient died prior to treatment and risk assignment	Biology Only Participants enrolled on the biology only arm
Overall Study Failed to achieve CR to Induction Therapy	0	1	0	0	0
Overall Study Physician Decision	0	1	2	0	0
Overall Study Participant or family decision to withdraw from protocol treatment	0	0	1	0	0
Overall Study Found to be ineligible	0	1	0	0	0
Overall Study Death	0	0	0	1	0
Overall Study Did not submit biology samples	0	0	0	0	13

Baseline Characteristics

Mature B-Cell Lymphoma And Leukemia Study III

Baseline characteristics by cohort

Measure	Group A n=5 Participants Completely resected stage I or completely resected abdominal stage II lesions.	Group B n=86 Participants All cases not eligible for Group A or Group C. (Murphy Stage III and non-CNS Stage IV)	Group C n=22 Participants Any CNS involvement and/or bone marrow involvement ≥ 25% blasts. For CNS involvement one or more of the following applies: 1. Any L3 blasts in CSF 2. Cranial nerve palsy (if not explained by extracranial tumor) 3. Clinical spinal cord compression 4. Isolated intracerebral mass 5. Parameningeal extension: cranial and/or spinal	Biology Only n=13 Participants Participants enrolled on the biology only arm	Total n=126 Participants Total of all reporting groups
Age, Continuous	13.7 years n=4 Participants	12.9 years n=50 Participants	14.4 years n=681 Participants	14.7 years n=639 Participants	13.4 years n=277 Participants
Sex: Female, Male Female	2 Participants n=4 Participants	21 Participants n=50 Participants	7 Participants n=681 Participants	2 Participants n=639 Participants	32 Participants n=277 Participants
Sex: Female, Male Male	3 Participants n=4 Participants	65 Participants n=50 Participants	15 Participants n=681 Participants	11 Participants n=639 Participants	94 Participants n=277 Participants
Race/Ethnicity, Customized White	4 Participants n=4 Participants	64 Participants n=50 Participants	18 Participants n=681 Participants	1 Participants n=639 Participants	87 Participants n=277 Participants
Race/Ethnicity, Customized Black	0 Participants n=4 Participants	12 Participants n=50 Participants	4 Participants n=681 Participants	0 Participants n=639 Participants	16 Participants n=277 Participants
Race/Ethnicity, Customized Asian	1 Participants n=4 Participants	4 Participants n=50 Participants	0 Participants n=681 Participants	11 Participants n=639 Participants	16 Participants n=277 Participants
Race/Ethnicity, Customized Multiple Race (Not Otherwise Specified)	0 Participants n=4 Participants	4 Participants n=50 Participants	0 Participants n=681 Participants	0 Participants n=639 Participants	4 Participants n=277 Participants
Race/Ethnicity, Customized Other	0 Participants n=4 Participants	2 Participants n=50 Participants	0 Participants n=681 Participants	1 Participants n=639 Participants	3 Participants n=277 Participants

PRIMARY outcome

Timeframe: 1 year after the participant is enrolled

Population: No data was generated for this measure due to the PI leaving St. Jude, COVID-19 disruptions, stricter regulations on international tumor material shipping, and unavailability of the required assay platform. One sample was received from Singapore, none from Egypt. No participant is analyzed, and no gene expression data is generated because the Affymetrix U133A GeneChip is no longer available. No participant will be analyzed, and no gene expression data will be generated in the future.

Gene expression levels in BL vs. non-BL will be analyzed through approximately 22,000 probesets on the Affymetrix U133A GeneChip by using two-factor analysis of variance model for each gene.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year after the participant is enrolled

Population: We were unable to evaluate this measure due to challenges such as the PI leaving St. Jude, COVID-19 disruptions, stricter regulations on shipping tumor materials internationally, and unavailability of the required assay platform. One sample was received from Singapore, none from Egypt. No participant is analyzed, and no CNV data is generated because the Affymetrix SNPChip platform is no longer available. No participant will be analyzed, and no CNV data will be generated in the future.

The prevalence of CNVs between different subtypes of childhood lymphomas and geographic regions will be reported and compared with exact chi-square or Fisher's test. The CNVs are derived from Affymetrix SNP arrays.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year after the participant is enrolled

Population: No data was generated for this measure due to PI leaving St. Jude, COVID-19 disruptions, stricter regulations on international tumor material shipping , unavailability of the required assay platform. 1 sample was received from Singapore, 0 from Egypt. No participant is analyzed, and no gene expression and CNV data is generated because the Affymetrix U133A GeneChip and SNPChip are unavailable. No participant will be analyzed, and no gene expression and CNV data will be generated in the future.

The association between the identified CNVs and gene expressions in the study cohort will be examined by using general linear models, and multiple tests will be considered. Gene expressions are measured by Affymetrix U133A arrays and CNVs are derived from Affymetrix SNP arrays.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year after the participant enrollment

Population: We cannot obtain samples from other countries; thus cannot evaluate this objective, due to the PI leaving, difficulties caused by COVID-19, and, most importantly, changes in regulations on sending tumor material from institutions in other countries. We received 1 sample from Singapore and none from Egypt. For international sites, no clinical, laboratory or outcome features are available. Among US samples, 1 was tested XLP positive. No data was generated from the Singapore sample.

Frequency of XLP mutation among boys will be calculated in each geographical region as well as in all regions pooled. The frequency is reported here as the number of boys with XLP gene mutations found in B-cell lymphomas boys.

Outcome measures

Measure	Biology Samples-United States (US) n=67 Participants US Participants Biology Samples	Biology Samples-Singapore n=1 Participants Singapore Participants Biology Samples	Biology Samples-Egypt Egypt Participants Biology Samples
Pattern and Frequency of XLP Gene Mutations Presenting With B-cell Lymphomas in the United States and Selected Geographic Regions	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 1 year after the participant is enrolled

Population: We were unable to fully evaluate this measure due to PI leaving St. Jude, COVID-19 disruptions, and stricter regulations on sending tumor material from other countries. We received 5 participants at our institution and none showed EBV positivity. No sample was received from international sites. No EBV positivity test will be performed, and no further data will be generated in the future.

Frequency of EBV-positive BL will be calculated for each geographical region.

Outcome measures

Measure	Biology Samples-United States (US) n=5 Participants US Participants Biology Samples	Biology Samples-Singapore Singapore Participants Biology Samples	Biology Samples-Egypt Egypt Participants Biology Samples
Frequency of EBV Protein Expression (e.g., EBNA 3) in EBV-positive Lymphomas	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years after completion of therapy

Population: The study objective requires to obtain and analyze long-term outcome (OS and EFS) and toxicities in Groups A, B, C only. Patients in the "Biology Only" group only provide samples and are not treated on this protocol. Therefore EFS, OS and toxicities are only analysed and reported for Groups A, B and C.

Overall survival (OS) will be estimated among eligible patients treated at SJCRH by the Kaplan-Meier estimator.

Outcome measures

Measure	Biology Samples-United States (US) n=5 Participants US Participants Biology Samples	Biology Samples-Singapore n=86 Participants Singapore Participants Biology Samples	Biology Samples-Egypt n=22 Participants Egypt Participants Biology Samples
Overall Survival	100 percentage of participants Interval 100.0 to 100.0	98.0 percentage of participants Interval 86.4 to 99.7	94.7 percentage of participants Interval 68.1 to 99.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years after completion of therapy

Population: The study objective requires to obtain and analyze long-term outcome (OS and EFS) and toxicities in Groups A, B, C only. Patients in the "Biology Only" group only provide samples and are not treated on this protocol. Therefore EFS, OS and toxicities are only analysed and reported for Groups A, B and C.

Event-free survival (EFS) will be estimated among eligible patients treated at SJCRH by the Kaplan-Meier estimator. The events will include: (1) death while in continuous CR, (2) relapse, (3) secondary malignancy, and (4) failure to achieve complete response (CR).

Outcome measures

Measure	Biology Samples-United States (US) n=5 Participants US Participants Biology Samples	Biology Samples-Singapore n=86 Participants Singapore Participants Biology Samples	Biology Samples-Egypt n=22 Participants Egypt Participants Biology Samples
Event-free Survival	100 percentage of participants Interval 100.0 to 100.0	90.6 percentage of participants Interval 82.0 to 95.2	81.8 percentage of participants Interval 58.5 to 92.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years after completion of therapy

Population: Only the 89 patients treated at St. Jude Children's Hospital are included in this analysis.The study objective requires to obtain and analyze long-term outcome (OS and EFS) and toxicities in Groups A, B, C only. Patients in the "Biology Only" group only provide samples and are not treated on this protocol. Therefore EFS, OS and toxicities are only analysed and reported for Groups A, B and C.

Complete response rate will be estimated with exact 95% CI based on the binomial distribution, and it will be reported as the percentage of patients who reached complete remission among eligible patients treated at SJCRH

Outcome measures

Measure	Biology Samples-United States (US) n=1 Participants US Participants Biology Samples	Biology Samples-Singapore n=71 Participants Singapore Participants Biology Samples	Biology Samples-Egypt n=17 Participants Egypt Participants Biology Samples
Complete Response Rate	100 percentage of participants Interval 2.5 to 100.0	90.14 percentage of participants Interval 80.74 to 95.94	82.35 percentage of participants Interval 56.57 to 96.2

Adverse Events

Group A

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 77 other events

Deaths: 1 deaths

Group C

Serious events: 0 serious events

Other events: 21 other events

Deaths: 1 deaths

Unknown Risk

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group A n=5 participants at risk Completely resected stage I or completely resected abdominal stage II lesions.	Group B n=86 participants at risk All cases not eligible for Group A or Group C. (Murphy Stage III and non-CNS Stage IV)	Group C n=22 participants at risk Any CNS involvement and/or bone marrow involvement ≥ 25% blasts. For CNS involvement one or more of the following applies: 1. Any L3 blasts in CSF 2. Cranial nerve palsy (if not explained by extracranial tumor) 3. Clinical spinal cord compression 4. Isolated intracerebral mass 5. Parameningeal extension: cranial and/or spinal	Unknown Risk Patient died prior to treatment and risk assignment
Blood and lymphatic system disorders Febrile neutropenia	60.0% 3/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	67.4% 58/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	81.8% 18/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Gastrointestinal disorders Mucositis oral	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	41.9% 36/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	77.3% 17/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Infections and infestations Enterocolitis infectious	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	15.1% 13/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	36.4% 8/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	10.5% 9/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	27.3% 6/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	5.8% 5/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	0.00% 0/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	9.3% 8/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	22.7% 5/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	9.3% 8/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	22.7% 5/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Infections and infestations Mucosal infection	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	8.1% 7/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	31.8% 7/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Infections and infestations Lung infection	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	8.1% 7/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	18.2% 4/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Vascular disorders Hypertension	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	8.1% 7/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	7.0% 6/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	22.7% 5/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Infections and infestations Upper respiratory infection	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	7.0% 6/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	7.0% 6/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	4.5% 1/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Vascular disorders Thromboembolic event	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	7.0% 6/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	0.00% 0/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	5.8% 5/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	22.7% 5/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Gastrointestinal disorders Colitis	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	5.8% 5/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	22.7% 5/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Blood and lymphatic system disorders Anemia	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	5.8% 5/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
General disorders Fever	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	5.8% 5/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Infections and infestations Skin infection	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	5.8% 5/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Nervous system disorders Headache	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	5.8% 5/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	0.00% 0/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Infections and infestations Sepsis	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	4.7% 4/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	27.3% 6/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Vascular disorders Hypotension	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	4.7% 4/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	22.7% 5/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Investigations Alanine aminotransferase increased	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	4.7% 4/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	18.2% 4/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Investigations Neutrophil count decreased	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	4.7% 4/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	4.7% 4/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Immune system disorders Allergic reaction	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	4.7% 4/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Investigations Platelet count decreased	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	4.7% 4/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	9.1% 2/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Renal and urinary disorders Acute kidney injury	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	4.7% 4/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	9.1% 2/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Gastrointestinal disorders Anal mucositis	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	4.7% 4/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	0.00% 0/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	3.5% 3/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	18.2% 4/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Investigations White blood cell decreased	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	3.5% 3/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	3.5% 3/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	3.5% 3/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Gastrointestinal disorders Oral pain	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	3.5% 3/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Gastrointestinal disorders Diarrhea	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	3.5% 3/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	9.1% 2/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Investigations Lymphocyte count decreased	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	2.3% 2/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	18.2% 4/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Investigations Aspartate aminotransferase increased	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	2.3% 2/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	18.2% 4/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Infections and infestations Catheter related infection	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	2.3% 2/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	9.1% 2/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Infections and infestations Sinusitis	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	2.3% 2/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	9.1% 2/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	1.2% 1/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Investigations Blood bilirubin increased	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	1.2% 1/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	13.6% 3/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Gastrointestinal disorders Typhlitis	0.00% 0/5 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	1.2% 1/86 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	9.1% 2/22 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.	— 0/0 • Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy. The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured. The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.

Additional Information

Raul Ribeiro, MD

St. Jude Children's Research Hospital

Phone: 901-595-3694

Email: raul.ribeiro@stjude.org

Results disclosure agreements

• Principal investigator is a sponsor employee MSA states Site is unable to publish until all completed case report forms have been delivered to Sponsor, (Study Completion). Site shall have the right to publish after publication of a multi-center publication coordinated by the Sponsor or (12) mths. after Study Completion; provided, that prior to any such publication or public release of such data, Site shall furnish Sponsor with a copy of any proposed publication at least (45)days in advance of the proposed publication or presentation date.
• Publication restrictions are in place

Restriction type: OTHER