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ALCI: LMP-specific T-cells for Patients With Relapsed EBV-positive Lymphoma

Sponsor
Baylor College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00062868
Collaborator
The Methodist Hospital Research Institute (Other), Center for Cell and Gene Therapy, Baylor College of Medicine (Other)
74
Enrollment
2
Locations
9
Arms
199
Actual Duration (Months)
37
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This protocol is broken up into 2 portions to determine the maximum tolerated dose for treating patients with a type of lymph gland disease.

The 1st portion, called ALASCER are for people with a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma or Lymphoepithelioma which has returned or may return or has not gone away after treatment, including the best treatment we know for Lymphoma. While the 2nd portion (ALCI) also includes Lymphoepithelioma, severe chronic active EBV (SCAEBC), and leiomyosarcoma.

Some patients with Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma, suggesting that it may play a role in causing Lymphoma. The cancer cells (in lymphoma) and some B cells (in SCAEBV) infected by EBV are able to hide from the body's immune system and escape destruction. Investigators want to see if special white blood cells, called T cells, that have been trained to kill EBV infected cells can survive in your blood and affect the tumor.

The investigators have used this sort of therapy to treat a different type of cancer that occurs after bone marrow or solid organ transplant called post transplant lymphoma. In this type of cancer the tumor cells have 9 proteins made by EBV on their surface. The investigators grew T cells in the laboratory that recognized all 9 proteins and were able to successfully prevent and treat post transplant lymphoma. However in Hodgkin disease and non-Hodgkin Lymphoma and SCAEBV, the tumor cells and B cells only express 2 EBV proteins. In a previous study we made T cells that recognized all 9 proteins and gave them to patients with Hodgkin disease. Some patients had a partial response to this therapy but no patients had a complete response. Investigators think one reason may be that many of the T cells reacted with proteins that were not on the tumor cells. In this present study we are trying to find out if we can improve this treatment by growing T cells that only recognize one of the proteins expressed on infected EBV Lymphoma cells called LMP-2a, and B cells called LMP1 and LMP2. These special T cells are called LMP specific cytotoxic T-lymphocytes (CTLs).

The purpose of the study is to find the largest safe dose of LMP specific cytotoxic T cells, to learn what the side effects are and to see whether this therapy might help patients with Hodgkin disease, non-Hodgkin Lymphoma, Lymphoepithelioma, SCAEBV or leiomyosarcoma.

Condition or Disease Intervention/Treatment Phase
  • Biological: LMP1/2 CTLs (ALCI - Group A)
  • Biological: LMP1/2 CTLs (ALCI - Group B)
  • Biological: LMP1/2 CTLs (ALCI - Group C)
  • Biological: LMP2 CTLs (ALSCER - Group A)
  • Biological: LMP2 CTLs (ALSCER - Group B)
  • Biological: LMP2 CTLs (ALSCER - Group C)
  • Biological: LMP1/2 CTLs (ALCI - Expansion - Group A)
  • Biological: LMP1/2 CTLs (ALCI - Expansion Group B)
  • Biological: LMP1/2 CTLs (ALCI - Expansion Group C)
 Phase 1

Detailed Description

ALASCER (Part 1 of 2)

We will generate autologous (or syngeneic) or allogeneic LMP2A-specific cytotoxic T-cells and adoptively transfer them to patients with relapsed EBV-positive Hodgkin's or non-Hodgkins Lymphoma or Lymphoepithelioma.

To initiate the LMP-specific CTL line, PBMC will be transduced with an adenovirus vector (Ad5f35-pp65) expressing the LMP2 antigen, at a viral particle (vp) to cell ratio of 30,000:1. For blood samples from normal donors, the monocyte fraction of PBMC may be transduced and will express and present LMP2 peptide epitopes to the LMP2-specific T cell fraction of the PBMC. This step will require 20 to 40 x 106 PBMC from about 40 mL of blood.

When a stronger stimulus is required to reactivate LMP2-specific T cell precursors (i.e. from patients PBMC), then we will make dendritic cell APCs by culture of PBMC-derived monocytes with cytokines (GM-CSF, IL-4) followed by transduction with Ad5f35-LMP2 (vp:cell ratio of 30000:1) and maturation with TNF-a and PGE1. These mature, transduced dendritic cells will be used to stimulate PBMC-derived T cells. In this case, dendritic cells will be prepared from about 40 mL of blood and the T cells will be derived from 20 to 40 mL of blood

To expand the LMP2-specific T cells we will use EBV-transformed B lymphoblastoid cell lines (EBV-LCLs) transduced with Ad5f35-LMP2 (vp:LCL ratio of 100,000:1). This transduction allows the EBV-LCLs to present LMP2 peptides to the T cells. EBV-LCLs are derived from PBMC-B lymphocytes by infection with a clinical grade, laboratory strain of Epstein-Barr virus (EBV). About 5 x 106 PBMC, or 5 to 10 mLs of blood is required to generate the EBV-LCL

At the end of the CTL culture period, the frequency of LMP2 specific CTL will be determined using tetramer reagents if available.

Transduction with the Neomycin Resistance Gene (optional - based on patient preference and availability of the vector). Established CTLs will be transduced with the retroviral vectors of the LN series.

Patients will be evaluated in the clinic and 2-4 doses of CTL will be administered each two weeks apart. Patients will be monitored for clinical toxicity by the NCI Common Toxicity Criteria Scale (Version 2.0 located at http://ctep.cancer.gov). In addition, we will determine the kinetics of CTL survival by monitoring the presence of the marker gene in peripheral blood in patients who receive marked cells. We will also analyze immunological parameters including phenotype and CTL frequencies by tetramer studies in patients who have HLA types where such reagents are available. Functional analyses will be done by cytotoxicity or ELISPOT/ELISA assays. The levels of EBV DNA in peripheral blood before and following infusion will be compared. A time period of 8 weeks will constitute the time for clinical safety monitoring. If patients have had a partial response or have stable disease they will be eligible to receive up to 6 further doses of CTLs, each of which will consist of the same number as their second injection.

ALCI (Part 2 of 2)

This is the 2nd part of the ALASCER study. ALCI reflected modification in the manufacturing process to enrich the CTL product for cells recognizing the LMP1 as well as the LMP2 antigen. The change in manufacturing required to enrich for both LMP2a and LMP1 is solely to substitute ALCI's Ad5f35LMP1/2 vector for the previously used Ad5f35LMP2 vector used to transduce the antigen presenting cells used ex vivo to stimulate the T cells during the manufacturing process in our GMP laboratories.

We initially used the AD5f35LMP2 vector and now use the Ad5f35LMP1/2 vector to generate LMP-specific CTL. Our preliminary data indicates that these two vectors are identical and produce similar enrichment of LMP2 specific CTL. By using the Ad5f35LMP1/2 vector instead of the Ad5f35 vector encoding LMP2 alone, we should better enrich T cell clones recognizing both of the LMP antigens expressed by the malignant cells in Hodgkin's disease and non-Hodgkin's Lymphoma. Our analysis strategies include plans to perform comparisons between these vector types.

Like the ALASCER product, the ALCI product continued to be a CTL line specific for EBV antigens but enriched for T cells recognizing LMP1 as well as LMP2. The ALASCER product already contains some LMP1 specific T cells along with T cell specific for other EBV antigens and the only change was enrich for these cells. Therefore the ALCI Ad5f35 LMP1/2 adenoviral vector is an ancillary reagent in the manufacturing process used only to transduce antigen presenting cells used as stimulator cells and is not infused in the final product. This vector completed testing and was approved for use under ALASCER IND (#6387).

Additionally, the ALASCER protocol design was amended to allow for the addition of a separate arm to the study depending on the vector used for the manufacturing process and the data is analyzed separately

In both ALASCER & ALCI, the cells will then be thawed and injected into the patient over 10 minutes. Initially, two doses of T cells will be given two weeks apart. If after the second infusion there is a reduction in the size of the lymphoma on CT or MRI scan as assessed by a radiologist, the patient can receive up to six additional doses of the T cells if the patient wishes. This is a dose escalation study which means that for some patients the second dose may be larger than the first. All of the treatments will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or the Methodist Hospital.

The patient will be followed after the injections. They will either be seen in the clinic or will be contacted by a research nurse yearly for 5 years. To learn more about the way the T cells are working in the patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before each infusion, and then 4 hours after each infusion (optional) and 3-4 days after each infusion (optional) and then weekly for 2 weeks after each infusion (total of 9 times). Two weeks after the last infusion, blood will then be taken again and then every 3 months for 1 year, then once a year for 5 years. Investigators will use this blood to see how long the T cells last and to look at the immune response to the patient's cancer.

ALCI (Expansion cohort)

Once the dose escalation safety phase of the study is completed (i.e. once at least 3 patients have been treated at dose level 3 and no treatment-related DLT has occurred), we plan to treat additional patients at dose level 1 to evaluate the immunological response in patients who receive CTL that have been generated using DC matured with the additional maturation cytokines (IL-1b and IL-6) in the presence of IL-15. We will treat an additional 30, 16, and 16 patients on Groups A, B and C, respectively.

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Administration of LMP-Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma (ALCI) / Previously Known as: Administration of Neomycin Resistance Gene Marked LMP2A-Specific Cytotoxic T-Lymphocytes to Patents With Relapsed EBV-Positive Lymphoma (ALASCAR)
Actual Study Start Date :
Sep 1, 2003
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: LMP1/2 CTLs (ALCI - Group A)

Patients receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/leiomyosarcoma or who are at risk for relapse

Biological: LMP1/2 CTLs (ALCI - Group A)
Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2 x 10^7 cells/m2; Day 14: 2 x 10^7 cells/m2 Dose Level Two Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2 Dose Level Three Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2
Experimental: LMP1/2 CTLs (ALCI - Group B)

Patients receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Biological: LMP1/2 CTLs (ALCI - Group B)
Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2 Dose Level Two Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2 Dose Level Three Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2
Experimental: LMP1/2 CTLs (ALCI - Group C)

Patients receiving CTLs following allogeneic stem cell transplant.

Biological: LMP1/2 CTLs (ALCI - Group C)
Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2 Dose Level Two Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2 Dose Level Three Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2
Experimental: LMP2A CTLs (ALASCER - Group A)

Patients receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/leiomyosarcoma or who are at risk for relapse

Biological: LMP2 CTLs (ALSCER - Group A)
Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2 x 10^7 cells/m2; Day 14: 2 x 10^7 cells/m2 Dose Level Two Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2 Dose Level Three Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2
Experimental: LMP2A CTLs (ALASCER - Group B)

Patients receiving CTLs as adjunctive therapy following autologous or syngeneic transplant

Biological: LMP2 CTLs (ALSCER - Group B)
Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2 Dose Level Two Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2 Dose Level Three Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2
Experimental: LMP2A CTLs (ALASCER - Group C)

Patients receiving CTLs following allogeneic stem cell transplant

Biological: LMP2 CTLs (ALSCER - Group C)
Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2 Dose Level Two Day 0: 2x10^7 cells/m2; Day 14: 1x10^8 cells/m2 Dose Level Three Day 0: 1x10^8 cells/m2; Day 14: 2x10^8 cells/m2
Experimental: LMP1/2 CTLs (ALCI - Expansion Group A)

Patients receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/leiomyosarcoma or who are at risk for relapse

Biological: LMP1/2 CTLs (ALCI - Expansion - Group A)
Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2 x 10^7 cells/m2; Day 14: 2 x 10^7 cells/m2
Experimental: LMP1/2 CTLs (ALCI - Expansion Group B)

Patients receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Biological: LMP1/2 CTLs (ALCI - Expansion Group B)
Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2
Experimental: LMP1/2 CTLs (ALCI - Expansion Group C)

Patients receiving CTLs following allogeneic stem cell transplant.

Biological: LMP1/2 CTLs (ALCI - Expansion Group C)
Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules: Dose Level One Day 0: 2x10^7 cells/m2; Day 14: 2x10^7 cells/m2

Outcome Measures

Primary Outcome Measures

  1. Dose Limiting Toxicity (DLT) Rate by the NCI Common Toxicity Criteria (CTCAE) v2.0 and the Method of Przepiorka et al (Protocol Appendix I) [6 weeks post second CLT infusion]

    Dose limiting toxicity (DLT) rate is the proportion of participants with DLT. DLT will be defined as any toxicity that is irreversible, life threatening or Grade 3-4 considered to be primarily related to the LMP-specific cytotoxic T-lymphocytes (CTL) injection or development of Grade III-IV Graft versus host disease (GVHD). Toxicity will be evaluated according to the CTCAE Version 2.0. GVHD will be graded by the method of Przepiorka et al (protocol Appendix I).

Secondary Outcome Measures

  1. Response Rate According to the Harmonization Project (Protocol 8.5.1) or RECIST Criteria. [Up to 4 months after the last infusion]

    Response rate is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) . All patients who receive the first infusion will be evaluable for response. In patients with detectable tumors and/or lymphadenopathy - response and progression will be evaluated using PET based imaging studies (whenever possible) based on the Harmonization Project (protocol 8.5.1). All available non-PET imaging studies will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.

  2. Grade III-IV Toxicity Rate in Participants Receiving an Extended Dosage Regimen According to the NCI Common Toxicity Criteria (CTCAE) Version 2.0 and the Method of Przepiorka et. al. (Protocol Appendix I). [6 weeks after the final injection]

    Grade III-IV toxicity rate is defined as the proportion of participants who receive an extended dose regimen and developed Grade III-IV toxicity attributable to the CTL infusions at any time during the extended dosing regimen. Toxicity will be evaluated according to the CTCAE Version 2.0. GVHD will be graded by the method of Przepiorka et al (protocol Appendix I).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

ALASCER (Part 1 of Study)

INCLUSION CRITERIA

  1. Any patient, regardless of age or sex, with EBV-positive Lymphoma, or lymphoepithelioma regardless of the histological subtype or EBV (associated)-T/NK-LPD.

In second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiply relapsed patients in remission who have a high risk of relapse) OR any patient with primary disease or in first remission if immunosuppressive chemotherapy is contraindicated, e.g. patients who develop Hodgkin disease after solid organ transplantation or if the Lymphoma is a second malignancy e.g. a Richters transformation of CLL. (Group A) OR In remission or with minimal residual disease status after autologous or syngeneic SCT for Hodgkin's or non-Hodgkin's Lymphoma or lymphoepithelioma. (Group B) OR In remission or with detectable disease after allogeneic SCT. (Group C)

  1. Patients with life expectancy > 6 weeks.

  2. Patients with a Karnofsky/Lansky score of > 50

  3. No severe intercurrent infection.

  4. Donor HIV negative (if autologous product - patient must be HIV negative)

  5. No evidence of GVHD > Grade II at time of enrollment.

  6. If post allogeneic SCT must not have less than 50% donor chimerism in either peripheral blood or bone marrow

  7. Patient, parent/guardian able to give informed consent.

  8. Patients with bilirubin <3x normal, AST <5x normal, and Hgb >8.0 (see Section 7.2).

  9. Patients with a creatinine <2x normal for age

  10. Patients should have been off other investigational therapy for one month prior to entry in this study.

EXCLUSION CRITERIA

  1. Patients with a life expectancy of <6 weeks.

  2. Patients with a Karnofsky/Lansky score of < 50.

  3. Patients with a severe intercurrent infection.

  4. Patients with bilirubin >3x normal. AST >5x normal or abnormal prothrombin time.

  5. Patients with a creatinine >2x normal for age

  6. Donors who are HIV positive (Patients who are HIV positive - if autologous product)

  7. Patients with GVHD Grades III-IV

  8. Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.

Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion after approval by the CCGT Protocol Review Committee and the FDA reviewer.

ALCI and ALCI Expansion (Part 2 of Study)

INCLUSION CRITERIA:
  1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, or lymphoepithelioma or leiomyosarcoma regardless of the histological subtype or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic EBV#

(#SCAEBV is defined as patients with high EBV viral load in plasma or PBMC (>4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV)

a - In second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiply relapsed patients currently in remission who have a high risk of relapse) OR with primary disease or in first or subsequent remission if immunosuppressive chemotherapy is contraindicated, e.g. patients who develop Hodgkin disease after solid organ transplantation or if the Lymphoma is a second malignancy e.g. a Richters transformation of CLL.(Group A)

OR

b - In remission or with minimal residual disease status after autologous or syngeneic SCT for Hodgkin's or non-Hodgkin's Lymphoma/Lymphoepithelioma/SCAEBV. (Group B)

OR

c - Patients in remission or with detectable disease after allogeneic SCT. (Group C)

  1. Patients with life expectancy 6 weeks or greater.

  2. Tumor tissue EBV positive

  3. Patients with a Karnofsky/Lansky score of 50 or greater

  4. Donor HIV negative (if autologous product - patient must be HIV negative)

  5. If post allogeneic SCT must not have less than 50% donor chimerism in either peripheral blood or bone marrow

  6. Patients with bilirubin 3x normal or less, AST 5x normal or less, and Hgb greater than 8.0

  7. Patients with a creatinine 2x normal or less for age

  8. Patients should have been off other investigational therapy for one month prior to entry in this study.

  9. Patient, parent/guardian able to give informed consent.

EXCLUSION CRITERIA:

  1. Patients with a severe intercurrent infection.

  2. Donors who are HIV positive or Patients who are HIV positive if autologous product to be used

  3. Patients with greater than Grade II GVHD

  4. Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Texas Children's Hospital Houston Texas United States 77030
2 The Methodist Hospital Houston Texas United States 77030

Sponsors and Collaborators

  • Baylor College of Medicine
  • The Methodist Hospital Research Institute
  • Center for Cell and Gene Therapy, Baylor College of Medicine

Investigators

  • Principal Investigator: Helen E Heslop, MD, Center for Cell and Gene Therapy, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Helen Heslop, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00062868
Other Study ID Numbers:
  • 9936-ALCI-ALASCAR
  • ALCI
  • ALASCAR
  • NCT00070226
  • NCT00671164
First Posted:
Jun 18, 2003
Last Update Posted:
Jun 9, 2020
Last Verified:
May 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Helen Heslop, Professor, Baylor College of Medicine
Lymphoma
EBV-T/NK lymphoproliferative disease
Severe Chronic EBV
LMP1/2
CTL
EBV
Relapse
LMP2A
Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Leiomyosarcoma

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Arm/Group Description Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).
Period Title: Dose Level 1
STARTED 3 0 0 3 0 0 4 0 0 3 0 0 3 0 0 3 0 0 16 2 3
COMPLETED 1 0 0 1 0 0 1 0 0 3 0 0 2 0 0 3 0 0 7 2 1
NOT COMPLETED 2 0 0 2 0 0 3 0 0 0 0 0 1 0 0 0 0 0 9 0 2
Period Title: Dose Level 1
STARTED 0 6 0 0 3 0 0 0 0 0 4 0 0 3 0 0 3 0 0 0 0
COMPLETED 0 3 0 0 1 0 0 0 0 0 3 0 0 2 0 0 0 0 0 0 0
NOT COMPLETED 0 3 0 0 2 0 0 0 0 0 1 0 0 1 0 0 3 0 0 0 0
Period Title: Dose Level 1
STARTED 0 0 3 0 0 0 0 0 0 0 0 5 0 0 3 0 0 4 0 0 0
COMPLETED 0 0 1 0 0 0 0 0 0 0 0 4 0 0 2 0 0 3 0 0 0
NOT COMPLETED 0 0 2 0 0 0 0 0 0 0 0 1 0 0 1 0 0 1 0 0 0

Baseline Characteristics

Arm/Group Title LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI - Expansion Group A) LMP1/2 CTLs (ALCI - Expansion Group B) LMP1/2 CTLs (ALCI - Expansion Group C) Total
Arm/Group Description Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2) Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2) Total of all reporting groups
Overall Participants 3 6 3 3 3 0 4 0 0 3 4 5 3 3 3 3 3 4 16 2 3 74
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
39
53
13
57
25
54
46
54
55
23
18
43
13
30
17.5
45
39
16
33.5
Sex: Female, Male (Count of Participants)
Female
2
66.7%
2
33.3%
1
33.3%
2
66.7%
1
33.3%
1
Infinity
1
25%
0
NaN
2
Infinity
0
0%
0
0%
1
20%
1
33.3%
2
66.7%
2
66.7%
7
233.3%
0
0%
2
50%
27
168.8%
Male
1
33.3%
4
66.7%
2
66.7%
1
33.3%
2
66.7%
3
Infinity
2
50%
4
Infinity
3
Infinity
3
100%
3
75%
2
40%
2
66.7%
1
33.3%
2
66.7%
9
300%
2
66.7%
1
25%
47
293.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
2
66.7%
0
0%
0
0%
0
NaN
0
0%
1
Infinity
1
Infinity
0
0%
1
25%
1
20%
2
66.7%
2
66.7%
0
0%
4
133.3%
0
0%
0
0%
14
87.5%
Not Hispanic or Latino
3
100%
6
100%
1
33.3%
3
100%
3
100%
4
Infinity
3
75%
3
Infinity
4
Infinity
3
100%
2
50%
2
40%
1
33.3%
1
33.3%
4
133.3%
12
400%
1
33.3%
3
75%
59
368.8%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
NaN
0
0%
0
NaN
0
NaN
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
0
0%
1
6.3%
Race/Ethnicity, Customized (Count of Participants)
American Indian
0
0%
0
0%
0
0%
0
0%
0
0%
0
NaN
0
0%
0
NaN
0
NaN
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
0
0%
1
25%
2
12.5%
Asian
0
0%
0
0%
0
0%
1
33.3%
0
0%
0
NaN
2
50%
0
NaN
1
Infinity
0
0%
0
0%
0
0%
1
33.3%
0
0%
0
0%
0
0%
0
0%
0
0%
5
31.3%
Black or African American
0
0%
2
33.3%
0
0%
0
0%
0
0%
0
NaN
0
0%
1
Infinity
0
NaN
0
0%
0
0%
1
20%
0
0%
0
0%
0
0%
1
33.3%
1
33.3%
0
0%
6
37.5%
White
3
100%
4
66.7%
3
100%
2
66.7%
3
100%
4
Infinity
1
25%
3
Infinity
4
Infinity
3
100%
3
75%
1
20%
2
66.7%
2
66.7%
4
133.3%
12
400%
1
33.3%
2
50%
57
356.3%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
NaN
0
0%
0
NaN
0
NaN
0
0%
0
0%
1
20%
0
0%
1
33.3%
0
0%
2
66.7%
0
0%
0
0%
4
25%

Outcome Measures

1. Primary Outcome
Title Dose Limiting Toxicity (DLT) Rate by the NCI Common Toxicity Criteria (CTCAE) v2.0 and the Method of Przepiorka et al (Protocol Appendix I)
Description Dose limiting toxicity (DLT) rate is the proportion of participants with DLT. DLT will be defined as any toxicity that is irreversible, life threatening or Grade 3-4 considered to be primarily related to the LMP-specific cytotoxic T-lymphocytes (CTL) injection or development of Grade III-IV Graft versus host disease (GVHD). Toxicity will be evaluated according to the CTCAE Version 2.0. GVHD will be graded by the method of Przepiorka et al (protocol Appendix I).
Time Frame 6 weeks post second CLT infusion

Outcome Measure Data

Analysis Population Description
Data is reported for all DLT evaluable participants who received CTL infusions and either completed the DLT assessment period or dropped off the study early due to DLT. One participant in the LMP1/2 CTLs (ALCI) - Group A Expansion was enrolled to this arm/group twice. DLT assessment data from the first enrollment is reported for this participant.
Arm/Group Title LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Arm/Group Description Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).
Measure Participants 3 6 3 3 3 0 3 0 0 3 3 4 3 3 3 3 3 4 15 2 2
Number (95% Confidence Interval) [proportion of participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
NaN
0
0%
0
NaN
0
NaN
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
2. Secondary Outcome
Title Response Rate According to the Harmonization Project (Protocol 8.5.1) or RECIST Criteria.
Description Response rate is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) . All patients who receive the first infusion will be evaluable for response. In patients with detectable tumors and/or lymphadenopathy - response and progression will be evaluated using PET based imaging studies (whenever possible) based on the Harmonization Project (protocol 8.5.1). All available non-PET imaging studies will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Time Frame Up to 4 months after the last infusion

Outcome Measure Data

Analysis Population Description
Data is reported for all participants who has received at least one infusion and has available response assessment data. One participant in LMP1/2 CTLs (ALCI) - Group A Expansion is excluded because of no available response data and one was enrolled to this arm/group twice that response assessment data from the first enrollment is reported.
Arm/Group Title LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Arm/Group Description Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).
Measure Participants 3 6 3 3 3 0 4 0 0 3 4 5 3 3 3 3 3 4 15 2 3
Number (95% Confidence Interval) [proportion of participants]
0.667
22.2%
0.833
13.9%
0.667
22.2%
0.333
11.1%
0.667
22.2%
0.75
Infinity
1
25%
0.75
Infinity
0.6
Infinity
1
33.3%
1
25%
1
20%
1
33.3%
0.667
22.2%
1
33.3%
0.733
24.4%
0.5
16.7%
0.333
8.3%
3. Secondary Outcome
Title Grade III-IV Toxicity Rate in Participants Receiving an Extended Dosage Regimen According to the NCI Common Toxicity Criteria (CTCAE) Version 2.0 and the Method of Przepiorka et. al. (Protocol Appendix I).
Description Grade III-IV toxicity rate is defined as the proportion of participants who receive an extended dose regimen and developed Grade III-IV toxicity attributable to the CTL infusions at any time during the extended dosing regimen. Toxicity will be evaluated according to the CTCAE Version 2.0. GVHD will be graded by the method of Przepiorka et al (protocol Appendix I).
Time Frame 6 weeks after the final injection

Outcome Measure Data

Analysis Population Description
Data is reported for participants who have received an extended dosage regimen.
Arm/Group Title LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Arm/Group Description Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).
Measure Participants 2 1 1 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 1 0 0
Number (95% Confidence Interval) [proportion of participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
NaN

Adverse Events

Time Frame Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 6 weeks after the last dosing of the study drug/biologic.
Adverse Event Reporting Description Zeros in the number of participants at risk for Other/Serious Adverse Events and the number of participants at risk for All-Cause Mortality are due to no participants treated at those arms/groups. One participant in the LMP1/2 CTLs (ALCI) - Group A Expansion was enrolled to this arm/group twice. All adverse event data is included for this participant regardless of enrollment.
Arm/Group Title LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Arm/Group Description Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2). Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).
All Cause Mortality
LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 2/3 (66.7%) 3/6 (50%) 0/3 (0%) 2/3 (66.7%) 2/3 (66.7%) 0/0 (NaN) 3/4 (75%) 0/0 (NaN) 0/0 (NaN) 0/3 (0%) 1/4 (25%) 1/5 (20%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 1/4 (25%) 7/16 (43.8%) 0/2 (0%) 1/3 (33.3%)
Serious Adverse Events
LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 2/3 (66.7%) 1/6 (16.7%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/0 (NaN) 1/4 (25%) 0/0 (NaN) 0/0 (NaN) 0/3 (0%) 1/4 (25%) 1/5 (20%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 1/4 (25%) 3/16 (18.8%) 0/2 (0%) 1/3 (33.3%)
Blood and lymphatic system disorders
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Cardiac disorders
Nodal/junctional arrhythmia/dysrhythmia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Cardiac-ischemia/infarction 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
General disorders
Fatigue (lethargy, malaise, asthenia) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Infections and infestations
Wound-Infectious 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Infection without neutropenia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Investigations
Bilirubin 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
SGOT (AST) (serum glutamic oxaloacetic transaminase) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Metabolism and nutrition disorders
Anorexia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Dehydration 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Hyponatremia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy-Other 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
SecondaryMalignancy-Other:PERIPHERALPRIMITIVENEUROECTODERMALTUMOR/ EWINGSARCOMA 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
SecondaryMalignancy-Other:SpindleCellSarcoma-periaortic 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
SecondaryMalignancy-Other:Squamouscellcarcinoma 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Nervous system disorders
Dizziness/lightheadedness 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Neuropathy - Motor 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Hypoxia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Skin and subcutaneous tissue disorders
Uticaria (hives, welts, wheals) 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Vascular disorders
Pulmonary-Other:pulmonaryembolism 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Other (Not Including Serious) Adverse Events
LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 3/3 (100%) 6/6 (100%) 3/3 (100%) 3/3 (100%) 3/3 (100%) 0/0 (NaN) 4/4 (100%) 0/0 (NaN) 0/0 (NaN) 3/3 (100%) 4/4 (100%) 5/5 (100%) 3/3 (100%) 3/3 (100%) 3/3 (100%) 3/3 (100%) 3/3 (100%) 4/4 (100%) 16/16 (100%) 2/2 (100%) 3/3 (100%)
Blood and lymphatic system disorders
Hemoglobin-Hgb 0/3 (0%) 0 2/6 (33.3%) 4 3/3 (100%) 3 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 3/4 (75%) 5 0/0 (NaN) 0 0/0 (NaN) 0 3/3 (100%) 3 1/4 (25%) 8 2/5 (40%) 6 1/3 (33.3%) 2 2/3 (66.7%) 4 1/3 (33.3%) 2 1/3 (33.3%) 1 2/3 (66.7%) 12 2/4 (50%) 8 7/16 (43.8%) 16 0/2 (0%) 0 2/3 (66.7%) 4
Transfusion: pRBCs 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 1/3 (33.3%) 3 0/4 (0%) 0 1/16 (6.3%) 3 0/2 (0%) 0 0/3 (0%) 0
Transfusion; Platelets 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 2/4 (50%) 12 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Transfusion; pRBC's 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Febrile Neutropenia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Lymphatics-Other 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 1/3 (33.3%) 1 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Lymphatics-Other:cervicaladenopathy 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Cardiac disorders
Sinus tachycardia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Palpitations 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Sinus Tachycardia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Ear and labyrinth disorders
Auditory/Hearing-Other 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Endocrine disorders
Hypothyroidism 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Eye disorders
Conjunctivitis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Dry Eye 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Ocular-Visual Other 0/3 (0%) 0 2/6 (33.3%) 5 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Ocular/Visual-Other:Periorbitalerythemaandswelling 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Ocular/Visual-Other:Visionhaziness 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Tearing (watery eyes) 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Gastrointestinal disorders
Constipation 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Diarrhea (without colostomy) 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 2 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Diarrhea patients without colostomy 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 1/4 (25%) 2 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Dyspepsia/Heartburn 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Gastrointestinal-Other 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 2 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Gastrointestinal-Other:erythemaofpharynx 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Nausea 0/3 (0%) 0 1/6 (16.7%) 4 1/3 (33.3%) 1 0/3 (0%) 0 1/3 (33.3%) 2 0/0 (NaN) 0 1/4 (25%) 2 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 2 3/16 (18.8%) 3 0/2 (0%) 0 1/3 (33.3%) 1
Pancreatitis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Vomiting 0/3 (0%) 0 2/6 (33.3%) 3 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Abdominal Pain or Cramping 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Abdominal pain or cramping 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 1/4 (25%) 1 2/16 (12.5%) 3 0/2 (0%) 0 0/3 (0%) 0
Pain-Other:Oralpain 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
General disorders
Edema 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Constitutional Symptoms-Other 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 2/4 (50%) 3 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Fatigue (lethargy, malaise, asthenia) 0/3 (0%) 0 3/6 (50%) 5 1/3 (33.3%) 1 1/3 (33.3%) 1 0/3 (0%) 0 0/0 (NaN) 0 4/4 (100%) 5 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 4 0/4 (0%) 0 2/5 (40%) 3 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 4/16 (25%) 7 0/2 (0%) 0 1/3 (33.3%) 1
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 2/3 (66.7%) 3 0/4 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/16 (12.5%) 2 0/2 (0%) 0 1/3 (33.3%) 1
Fever-absence of Neutropenia 0/3 (0%) 0 3/6 (50%) 4 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 2/4 (50%) 4 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Rigors, chills 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Rigors/Chills 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Sweating (Diaphoresis) 1/3 (33.3%) 1 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Sweating (diaphoresis) 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Hemorrhage/Bleeding w/gr 3/4 Thrombocytopenia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Chest Pain (non-cardiac, non-pleuritic) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Chest pain (non-cardiac and non-pleuritic) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Pain-Other 0/3 (0%) 0 1/6 (16.7%) 1 2/3 (66.7%) 3 1/3 (33.3%) 1 0/3 (0%) 0 0/0 (NaN) 0 3/4 (75%) 9 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 2/4 (50%) 2 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Hepatobiliary disorders
Hepatic-Other 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 2 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Immune system disorders
Allergy/Immunology-Other:lymphnodeswelling 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Allergy/Immunology-Other:moresignificanthistaminereaction 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Infections and infestations
Wound-Infectious 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Stomatitis/pharyngitis (oral/pharyngeal mucositis) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 2/3 (66.7%) 2 2/4 (50%) 3 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Infection without Neutropenia 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Infection without neutropenia 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 1 1/4 (25%) 1 1/5 (20%) 1 1/3 (33.3%) 2 0/3 (0%) 0 2/3 (66.7%) 2 0/3 (0%) 0 2/3 (66.7%) 2 2/4 (50%) 6 11/16 (68.8%) 14 0/2 (0%) 0 3/3 (100%) 6
Injury, poisoning and procedural complications
Bruising (absence of thrombocytopenia grade 3/4) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Bruising (in absence of grade 3 or 4 thrombocytopenia) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 2/3 (66.7%) 2 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Neurology-Other:Fall 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Investigations
Leukocytes (total WBC) 0/3 (0%) 0 2/6 (33.3%) 4 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 1 1/4 (25%) 5 3/5 (60%) 4 3/3 (100%) 8 2/3 (66.7%) 14 2/3 (66.7%) 3 3/3 (100%) 8 2/3 (66.7%) 23 3/4 (75%) 23 13/16 (81.3%) 26 2/2 (100%) 2 2/3 (66.7%) 4
Leukopenia (total WBC) 1/3 (33.3%) 1 3/6 (50%) 4 1/3 (33.3%) 1 1/3 (33.3%) 1 1/3 (33.3%) 1 0/0 (NaN) 0 2/4 (50%) 5 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Lymphopenia 0/3 (0%) 0 5/6 (83.3%) 15 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 2/4 (50%) 7 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 2 2/4 (50%) 5 4/5 (80%) 7 3/3 (100%) 6 1/3 (33.3%) 10 2/3 (66.7%) 5 2/3 (66.7%) 3 3/3 (100%) 9 2/4 (50%) 18 10/16 (62.5%) 28 1/2 (50%) 1 1/3 (33.3%) 3
Neutrophils/granulocytes (ANC/AGC) 2/3 (66.7%) 6 4/6 (66.7%) 5 2/3 (66.7%) 2 1/3 (33.3%) 3 0/3 (0%) 0 0/0 (NaN) 0 2/4 (50%) 8 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 2 1/4 (25%) 9 3/5 (60%) 3 2/3 (66.7%) 5 2/3 (66.7%) 17 1/3 (33.3%) 1 3/3 (100%) 8 2/3 (66.7%) 24 3/4 (75%) 24 9/16 (56.3%) 17 0/2 (0%) 0 2/3 (66.7%) 2
Platelets 2/3 (66.7%) 5 2/6 (33.3%) 6 1/3 (33.3%) 1 0/3 (0%) 0 1/3 (33.3%) 1 0/0 (NaN) 0 3/4 (75%) 12 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 1 2/4 (50%) 4 1/5 (20%) 1 1/3 (33.3%) 3 1/3 (33.3%) 3 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 8 3/4 (75%) 9 6/16 (37.5%) 13 0/2 (0%) 0 0/3 (0%) 0
Fibrinogen 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 5 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Partial thromboplastin time (PTT) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 3 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Prothrombin time (PT) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 4 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Weight loss 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Alkaline phosphatase 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 2 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Bilirubin 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 4 0/4 (0%) 0 1/16 (6.3%) 1 1/2 (50%) 1 1/3 (33.3%) 2
SGOT (AST) (serum glutamic oxaloacetic transaminase) 0/3 (0%) 0 2/6 (33.3%) 2 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 4 2/4 (50%) 6 2/5 (40%) 2 0/3 (0%) 0 3/3 (100%) 4 1/3 (33.3%) 1 1/3 (33.3%) 1 3/3 (100%) 11 2/4 (50%) 4 5/16 (31.3%) 8 1/2 (50%) 2 2/3 (66.7%) 3
SGPT (ALT) (serum glutamic pyruvic transaminase) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 1/5 (20%) 2 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Alkaline Phosphatase 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 1/3 (33.3%) 1 0/0 (NaN) 0 1/4 (25%) 2 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
SGOT(AST) (serum glutamic oxal. Transaminase) 1/3 (33.3%) 1 1/6 (16.7%) 1 1/3 (33.3%) 1 1/3 (33.3%) 3 1/3 (33.3%) 1 0/0 (NaN) 0 3/4 (75%) 6 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
SGPT(ALT) (seurm glutamic pyruric trans.) 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 1/3 (33.3%) 1 0/0 (NaN) 0 2/4 (50%) 5 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Amylase 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 3 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 4 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Bicarbonate 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 2/4 (50%) 2 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 4 4/4 (100%) 5 2/5 (40%) 2 1/3 (33.3%) 2 1/3 (33.3%) 1 2/3 (66.7%) 4 2/3 (66.7%) 3 2/3 (66.7%) 3 2/4 (50%) 10 2/16 (12.5%) 2 0/2 (0%) 0 2/3 (66.7%) 2
Hypercholesterolemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Lipase 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 4 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 2 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Metabolic/Laboratory-Other:Hyperchloremia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Metabolic/Laboratory-Other:Hypochloremia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 2/3 (66.7%) 3 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Creatinine 2/3 (66.7%) 3 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 2/4 (50%) 2 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 1 1/4 (25%) 2 1/5 (20%) 1 1/3 (33.3%) 1 1/3 (33.3%) 1 2/3 (66.7%) 3 1/3 (33.3%) 1 0/3 (0%) 0 2/4 (50%) 4 2/16 (12.5%) 5 0/2 (0%) 0 0/3 (0%) 0
Renal/Genitourinary-Other 1/3 (33.3%) 2 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/0 (NaN) 0 2/4 (50%) 4 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Renal/Genitourinary-Other:BUN 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Metabolism and nutrition disorders
Anorexia 0/3 (0%) 0 0/6 (0%) 0 2/3 (66.7%) 3 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 2/3 (66.7%) 3
Hepatic-Other:Hypoproteinemia 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Hypoalbuminemia 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 1 1/5 (20%) 1 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 4 1/4 (25%) 1 4/16 (25%) 4 0/2 (0%) 0 1/3 (33.3%) 2
Hypoalbuminemia 0/3 (0%) 0 1/6 (16.7%) 1 1/3 (33.3%) 1 1/3 (33.3%) 1 1/3 (33.3%) 1 0/0 (NaN) 0 2/4 (50%) 3 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Acidosis (metabolic or respiratory) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 2 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Alkalosis (metabolic or respiratory) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 3 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Hypercalcemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Hyperglycemia 1/3 (33.3%) 4 2/6 (33.3%) 4 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 10 2/4 (50%) 11 1/5 (20%) 4 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 1/3 (33.3%) 3 3/3 (100%) 7 0/4 (0%) 0 2/16 (12.5%) 12 0/2 (0%) 0 0/3 (0%) 0
Hyperkalemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 2/4 (50%) 3 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 3 2/4 (50%) 4 2/5 (40%) 5 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 2/3 (66.7%) 2 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Hypermagnesemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 2 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 1/16 (6.3%) 2 0/2 (0%) 0 0/3 (0%) 0
Hypernatremia 1/3 (33.3%) 1 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 2/4 (50%) 3 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/16 (12.5%) 2 0/2 (0%) 0 0/3 (0%) 0
Hypertriglyceridemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 2 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 1/3 (33.3%) 1 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Hyperuricemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 2/3 (66.7%) 2 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 2 0/2 (0%) 0 0/3 (0%) 0
Hypocalcemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 7 1/5 (20%) 1 0/3 (0%) 0 1/3 (33.3%) 1 1/3 (33.3%) 1 1/3 (33.3%) 1 2/3 (66.7%) 11 0/4 (0%) 0 3/16 (18.8%) 6 0/2 (0%) 0 0/3 (0%) 0
Hypoglycemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 2 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Hypokalemia 1/3 (33.3%) 2 4/6 (66.7%) 5 2/3 (66.7%) 3 1/3 (33.3%) 1 1/3 (33.3%) 2 0/0 (NaN) 0 3/4 (75%) 4 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 2 2/4 (50%) 6 3/5 (60%) 5 1/3 (33.3%) 1 2/3 (66.7%) 3 0/3 (0%) 0 1/3 (33.3%) 3 2/3 (66.7%) 12 2/4 (50%) 11 4/16 (25%) 8 1/2 (50%) 1 2/3 (66.7%) 2
Hypomagnesmia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 2/3 (66.7%) 6 0/4 (0%) 0 2/16 (12.5%) 2 0/2 (0%) 0 0/3 (0%) 0
Hyponatremia 1/3 (33.3%) 3 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 2 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 1 1/4 (25%) 3 1/5 (20%) 1 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 2 1/4 (25%) 1 2/16 (12.5%) 3 0/2 (0%) 0 2/3 (66.7%) 8
Hypophosphatemia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 3 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 4 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Metabolic/Laboratory-Other 1/3 (33.3%) 1 1/6 (16.7%) 1 1/3 (33.3%) 2 0/3 (0%) 0 2/3 (66.7%) 2 0/0 (NaN) 0 4/4 (100%) 7 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Musculoskeletal and connective tissue disorders
Musculoskelatal-Other 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Arthralgia (joint pain) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 3 1/4 (25%) 1 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Bone Pain 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Myalgia (muscle pain) 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 1/16 (6.3%) 1 0/2 (0%) 0 1/3 (33.3%) 1
Pain-Other:Ankle,backandknee 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Pain-Other:Legpain 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Pain-Other:bodyaches 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Pain-Other:generalizedaches&pains 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Pain-Other:lefthandpain 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Pain-Other:leftshoulder 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Pain-Other:upperrightarm 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death not associated with CTCAE term - Disease progression NOS 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Tumor pain (onset or exacerbation of tumor pain due to treatment) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
SecondaryMalignancy-Other:Highgradesarcoma 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
SecondaryMalignancy-Other:MyelodysplasticSyndrome 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
SecondaryMalignancy-Other:squamouscellcarcinoma 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Nervous system disorders
Taste disturbance (dysgeusia) 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Depressed level of consciousness 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 2
Dizziness/Lightheadedness 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Dizziness/lightheadedness 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 2/16 (12.5%) 3 0/2 (0%) 0 0/3 (0%) 0
Neuropathy - motor 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Neuropathy-Sensory 0/3 (0%) 0 1/6 (16.7%) 2 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Headache 1/3 (33.3%) 1 4/6 (66.7%) 6 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 1/4 (25%) 2 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Neuropathic Pain 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Psychiatric disorders
Insomnia 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Mood alteration-anxiety, agitation 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Dysuria (painful urination) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 2 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Proteinuria 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Urinary Frequency/Urgency 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) 0/3 (0%) 0 2/6 (33.3%) 2 2/3 (66.7%) 4 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 2/4 (50%) 2 0/0 (NaN) 0 0/0 (NaN) 0 2/3 (66.7%) 3 0/4 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 1/3 (33.3%) 1
Allergy/Immunology-Other 0/3 (0%) 0 0/6 (0%) 0 1/3 (33.3%) 2 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 2/4 (50%) 3 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Allergy/Immunology-Other:Sorethroat 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Allergy/Immunology-Other:excessmucus 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Epistaxis 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Pain-Other:SORETHROAT 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Cough 0/3 (0%) 0 3/6 (50%) 3 1/3 (33.3%) 2 0/3 (0%) 0 1/3 (33.3%) 1 0/0 (NaN) 0 1/4 (25%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 1/3 (33.3%) 2
Dyspnea (shortness of breath) 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 1/3 (33.3%) 1
Pulmonary-Other 1/3 (33.3%) 1 1/6 (16.7%) 1 2/3 (66.7%) 6 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Pulmonary-Other:Reactiveairwaydisease 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Pulmonary-Other:SORETHROAT 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Pulmonary-Other:Tachypnea 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Cough 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 2/3 (66.7%) 2 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Pulmonary-Other:RespiratoryFailure 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Pulmonary-Other:sorethroat 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 1/5 (20%) 2 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other 0/3 (0%) 0 1/6 (16.7%) 1 1/3 (33.3%) 1 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/4 (25%) 1 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Dermatology/Skin-Other:Face&neckpimples 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 2 0/2 (0%) 0 0/3 (0%) 0
Dermatology/Skin-Other:SpongioticDermatitis 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Dermatology/Skin-Other:pimples 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 1/16 (6.3%) 1 0/2 (0%) 0 0/3 (0%) 0
Dry Skin 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 5 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 1 1/5 (20%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Pruritus 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 2 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 1/4 (25%) 1 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1
Rash/Desquamation 0/3 (0%) 0 2/6 (33.3%) 2 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 4 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Rash/desquamation 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 0/3 (0%) 0 3/4 (75%) 4 2/16 (12.5%) 3 0/2 (0%) 0 0/3 (0%) 0
Petechiae/Purpura(hemorrhage/bleeding skin/mucosa) 0/3 (0%) 0 0/6 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 1/4 (25%) 2 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Vascular disorders
Hypertension 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 3 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0
Hypotension 0/3 (0%) 0 1/6 (16.7%) 2 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 1/3 (33.3%) 1 0/4 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 2 0/3 (0%) 0 0/3 (0%) 0 1/3 (33.3%) 1 1/3 (33.3%) 1 1/4 (25%) 1 1/16 (6.3%) 1 0/2 (0%) 0 1/3 (33.3%) 1
Hot Flashes/Flushes 0/3 (0%) 0 1/6 (16.7%) 1 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/4 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/3 (0%) 0 0/4 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/3 (0%) 0 0/4 (0%) 0 0/16 (0%) 0 0/2 (0%) 0 0/3 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Helen E. Heslop
Organization Baylor College of Medicine
Phone 832-824-4662
Email hheslop@bcm.edu
Responsible Party:
Helen Heslop, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00062868
Other Study ID Numbers:
  • 9936-ALCI-ALASCAR
  • ALCI
  • ALASCAR
  • NCT00070226
  • NCT00671164
First Posted:
Jun 18, 2003
Last Update Posted:
Jun 9, 2020
Last Verified:
May 1, 2020