Trial Outcomes & Findings for A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients (NCT NCT02578641)

NCT ID: NCT02578641

Last Updated: 2023-06-28

Results Overview

Efficacy of EBV-CTL following first line chemotherapy was compared to chemotherapy alone in terms of OS of subjects with advanced nasopharyngeal carcinoma. Overall survival was defined as the duration in months from the day of randomization until death from any cause for a subject known to be deceased, or censored at the last contact date that a subject was known to be alive or lost to follow-up.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 330 participants
• Primary outcome timeframe: From randomization until death, assessed up to 7 years. Survivors and lost to follow-up subjects were censored at the date of last contact. Survival follow-up was done every 12 weeks from end of treatment.
• Results posted on: 2023-06-28

Participant Flow

This study randomized 330 subjects at 23 sites in Asia and 7 sites in the United States from 17 Jul 2014 to 28 Feb 2022.

Subjects were randomized in a 1:1 ratio to receive open-label Gemcitabine and Carpoblatin followed by Autologus Epstein-Barr Virus-specific Cytotoxic T Cells (Chemo + EBV-CTL) versus Gemcitabine and Carboplatin alone (Chemo Only).

Participant milestones

Measure	Chemo + EBV-CTL Two consecutive stages: * 4 cycles of combination IV gemcitabine (1000 mg/m2) and IV carboplatin (AUC2) on Days 1, 8, 15 every 28 days. Option to add 1 to 2 cycles (i.e., up to 6 cycles total) * 6 cycles of immunotherapy with EBV-specific CTL (1 x 10\^8 cells/m2) starting 2 to 4 weeks after last chemotherapy treatment. Subsequent chemotherapy cycles occurred 2 weeks after the first immunotherapy dose, 6 weeks after the second immunotherapy dose, and every 8 weeks thereafter	Chemo Only 6 cycles of combination IV gemcitabine (1000 mg/m2) and IV carboplatin (AUC2) on Days 1, 8, 15 every 28 days.
Overall Study STARTED	164	166
Overall Study Treatment Received: Gemcitabine/ Carboplatin	163	162
Overall Study Treatment Received: EBV-CTL	133	0
Overall Study COMPLETED	55	99
Overall Study NOT COMPLETED	109	67

Reasons for withdrawal

Measure	Chemo + EBV-CTL Two consecutive stages: * 4 cycles of combination IV gemcitabine (1000 mg/m2) and IV carboplatin (AUC2) on Days 1, 8, 15 every 28 days. Option to add 1 to 2 cycles (i.e., up to 6 cycles total) * 6 cycles of immunotherapy with EBV-specific CTL (1 x 10\^8 cells/m2) starting 2 to 4 weeks after last chemotherapy treatment. Subsequent chemotherapy cycles occurred 2 weeks after the first immunotherapy dose, 6 weeks after the second immunotherapy dose, and every 8 weeks thereafter	Chemo Only 6 cycles of combination IV gemcitabine (1000 mg/m2) and IV carboplatin (AUC2) on Days 1, 8, 15 every 28 days.
Overall Study Adverse Event	5	15
Overall Study Death	16	8
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	14	7
Overall Study Progressive Disease	69	21
Overall Study No Study Drug	2	0
Overall Study Randomized by Mistake with Study Treatment	0	1
Overall Study Non-compliance with Study Schedule	1	0
Overall Study Other	1	10
Overall Study Not treated	1	4

Baseline Characteristics

A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients

Baseline characteristics by cohort

Measure	Chemo + EBV-CTL n=164 Participants gemcitabine/carboplatin and EBV-CTL	Chemo Only n=166 Participants gemcitabine/carboplatin	Total n=330 Participants Total of all reporting groups
Region of Enrollment Malaysia	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Region of Enrollment Thailand	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants
Age, Continuous	53 years n=5 Participants	55 years n=7 Participants	54 years n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants	126 Participants n=7 Participants	248 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	156 Participants n=5 Participants	157 Participants n=7 Participants	313 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	160 Participants n=5 Participants	160 Participants n=7 Participants	320 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Singapore	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment Taiwan	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Nasopharyngeal Cancer (NPC) stage at time of study entry Stage II	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants
Nasopharyngeal Cancer (NPC) stage at time of study entry Stage III	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Nasopharyngeal Cancer (NPC) stage at time of study entry Stage IVA	14 Participants n=5 Participants	24 Participants n=7 Participants	38 Participants n=5 Participants
Nasopharyngeal Cancer (NPC) stage at time of study entry Stage IVB	23 Participants n=5 Participants	34 Participants n=7 Participants	57 Participants n=5 Participants
Nasopharyngeal Cancer (NPC) stage at time of study entry Stage IVC	94 Participants n=5 Participants	84 Participants n=7 Participants	178 Participants n=5 Participants
Nasopharyngeal Cancer (NPC) stage at time of study entry Others	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Disease Status per Randomization Stratification Metastatic	115 Participants n=5 Participants	116 Participants n=7 Participants	231 Participants n=5 Participants
Disease Status per Randomization Stratification Locally recurrent	49 Participants n=5 Participants	50 Participants n=7 Participants	99 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 0	87 Participants n=5 Participants	99 Participants n=7 Participants	186 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 1	73 Participants n=5 Participants	65 Participants n=7 Participants	138 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ECOG PS 2	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization until death, assessed up to 7 years. Survivors and lost to follow-up subjects were censored at the date of last contact. Survival follow-up was done every 12 weeks from end of treatment.

Population: Intent-to-Treat Analysis Set

Efficacy of EBV-CTL following first line chemotherapy was compared to chemotherapy alone in terms of OS of subjects with advanced nasopharyngeal carcinoma. Overall survival was defined as the duration in months from the day of randomization until death from any cause for a subject known to be deceased, or censored at the last contact date that a subject was known to be alive or lost to follow-up.

Outcome measures

Measure	Chemo + EBV-CTL n=164 Participants gemcitabine+carboplatin and EBV-CTL	Chemo Only n=166 Participants gemcitabine+carboplatin
Overall Survival (OS) of Subjects With Advanced Nasopharyngeal Carcinoma.	25 Months Interval 19.7 to 31.8	24.9 Months Interval 19.7 to 32.8

SECONDARY outcome

Timeframe: From randomization until first occurrence of disease progression or death of any cause, whichever occurred first, assessed up to 7 years. Subjects who received subsequent anti-cancer therapy were censored at the date of last tumor assessment.

Population: Intent-to-Treat Analysis Set

Progression-free survival was defined as the duration from randomization to the first occurrence of documented disease progression [based on imaging results] or death from any cause, whichever occurred first.

Outcome measures

Measure	Chemo + EBV-CTL n=164 Participants gemcitabine+carboplatin and EBV-CTL	Chemo Only n=166 Participants gemcitabine+carboplatin
Progression-free Survival (PFS) of Subjects With Advanced Nasopharyngeal Carcinoma.	7.9 Months Interval 7.1 to 8.2	8.5 Months Interval 8.1 to 9.6

SECONDARY outcome

Timeframe: From randomization until End of Treatment, an average of 13 months for the gemcitabine+carboplatin and EBVCTL arm and 6 months for the gemcitabine+carboplatin only arm.

Population: Intent-to-Treat Analysis Set

Overall response rate was assessed by sites using computed tomography/magnetic resonance imaging based on RECIST version 1.1, which defined Complete Response (CR) as disappearance of all lesions and pathologic lymph nodes; Partial Response (PR) as >=30% decrease in the sum of the longest diameter (SLD) of target lesions, no new lesions, no progression of non-target lesions; Stable disease (SD) as no PR and no progressive disease (PD); PD as >=20% increase SLD compared to smallest SLD or progression of non-target lesions or new lesions. The ORR for each treatment arm was comprised of the proportion of subjects who achieved a best overall response of CR or PR while on treatment (until End of Treatment visit), taking as reference the tumor measurement at baseline. Subjects who achieved CR or PR are responders, otherwise are non-responders.

Outcome measures

Measure	Chemo + EBV-CTL n=164 Participants gemcitabine+carboplatin and EBV-CTL	Chemo Only n=166 Participants gemcitabine+carboplatin
Overall Response Rate (ORR) of Subjects With Advanced Nasopharyngeal Carcinoma. Responders (CR/PR)	100 Participants	105 Participants
Overall Response Rate (ORR) of Subjects With Advanced Nasopharyngeal Carcinoma. Non-Responders (SD/PD/NA/NE)	64 Participants	61 Participants

SECONDARY outcome

Timeframe: From randomization until End of Treatment, an average of 13 months for the gemcitabine+carboplatin and EBVCTL arm and 6 months for the gemcitabine+carboplatin only arm.

Population: Intent-to-Treat Analysis Set

Clinical benefit rate (CBR) was assessed using computed tomography/magnetic resonance imaging based on RECIST version 1.1., which defined CR as disappearance of all lesions and pathologic lymph nodes; PR as >=30% decrease in the sum of the longest diameter (SLD) of target lesions, no new lesions, no progression of non-target lesions; SD as no PR and no PD; PD as >=20% increase SLD compared to smallest SLD or progression of non-target lesions or new lesions. CBR was defined as the proportion of subjects who achieved CR, PR, or SD while on treatment (until End of Treatment visit), taking as reference the tumor measurement at baseline.

Outcome measures

Measure	Chemo + EBV-CTL n=164 Participants gemcitabine+carboplatin and EBV-CTL	Chemo Only n=166 Participants gemcitabine+carboplatin
Clinical Benefit Rate (CBR) of Subjects With Advanced Nasopharyngeal Carcinoma. No Clinical Benefit (Otherwise)	25 Participants	30 Participants
Clinical Benefit Rate (CBR) of Subjects With Advanced Nasopharyngeal Carcinoma. Clinical Benefit (CR/PR/2 consecutive SD)	139 Participants	136 Participants

SECONDARY outcome

Timeframe: From randomization until End of Treatment, an average of 13 months for the gemcitabine+carboplatin and EBVCTL arm and 6 months for the gemcitabine+carboplatin only arm.

Population: Intent-to-Treat Analysis Set

Best overall response (BOR) was assessed using computed tomography/magnetic resonance imaging based on RECIST version 1.1., which defined CR as disappearance of all lesions and pathologic lymph nodes; PR as >=30% decrease in the sum of the longest diameter (SLD) of target lesions, no new lesions, no progression of non-target lesions; SD as no PR and no PD; PD as >=20% increase SLD compared to smallest SLD or progression of non-target lesions or new lesions. The BOR of each treatment arm consisted of CR, PR, SD, PD, NE, and NA while on treatment (until End of Treatment visit), taking as reference the tumor measurement at baseline. The ORR was comprised of the proportion of subjects who achieved a BOR of CR or PR.

Outcome measures

Measure	Chemo + EBV-CTL n=164 Participants gemcitabine+carboplatin and EBV-CTL	Chemo Only n=166 Participants gemcitabine+carboplatin
Best Overall Response (BOR) of Subjects With Advanced Nasopharyngeal Carcinoma. Complete Response (CR)	6 Participants	14 Participants
Best Overall Response (BOR) of Subjects With Advanced Nasopharyngeal Carcinoma. Partial Response (PR)	94 Participants	91 Participants
Best Overall Response (BOR) of Subjects With Advanced Nasopharyngeal Carcinoma. Stable Disease (SD)	45 Participants	41 Participants
Best Overall Response (BOR) of Subjects With Advanced Nasopharyngeal Carcinoma. Progressive Disease (PD)	9 Participants	10 Participants
Best Overall Response (BOR) of Subjects With Advanced Nasopharyngeal Carcinoma. NE (Not evaluable)	1 Participants	0 Participants
Best Overall Response (BOR) of Subjects With Advanced Nasopharyngeal Carcinoma. NA (Not applicable)	9 Participants	10 Participants

Adverse Events

Chemo + EBV-CTL

Serious events: 68 serious events

Other events: 163 other events

Deaths: 16 deaths

Chemo Only

Serious events: 46 serious events

Other events: 162 other events

Deaths: 8 deaths

Serious adverse events

Measure	Chemo + EBV-CTL n=163 participants at risk gemcitabine+carboplatin + EBV-CTL	Chemo Only n=162 participants at risk gemcitabine+carboplatin
Infections and infestations Pneumonia	5.5% 9/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	4.9% 8/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Anemia	5.5% 9/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	3.7% 6/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Blood and lymphatic system disorders febrile neutropenia	3.1% 5/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	2.5% 4/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
General disorders Pyrexia	4.3% 7/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	2.5% 4/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer	5.5% 9/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	3.7% 6/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Metabolism and nutrition disorders Hyponatremia	6.1% 10/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	1.2% 2/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Septic shock	1.8% 3/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Cellulitis	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	1.2% 2/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Injection site infection	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	1.2% 2/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Sepsis	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	1.9% 3/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Bacteremia	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Bacterial Infection	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Conjunctivitis	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Hepatic infection	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Lower respiratory tract infection	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Meningitis bacterial	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Pulmonary tuberculosis	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Sinusitis	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Staphylococcal infection	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Upper respiratory tract infection	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Urinary tract infection	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Neutropenia	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Pancytopenia	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Thrombocytopenia	1.2% 2/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Anaemia of malignant disease	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Antiphospholipid syndrome	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Bicytopenia	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Blood disorder	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
General disorders Disease progression	1.2% 2/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
General disorders Death	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
General disorders Chest pain	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
General disorders Facial pain	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
General disorders Fatigue	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
General disorders Mucosal inflammation	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
General disorders Multiple organ dysfunction syndrome	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
General disorders Nodule	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
General disorders Pain	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
General disorders Sudden death	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer stage IV	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Vomiting	1.2% 2/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	1.2% 2/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Constipation	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Diarrhea	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Dysphagia	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Gastrointestinal hemorrhage	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Gastrointestinal obstruction	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Hemorrhoids	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Mouth hemorrhage	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Nausea	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Rectal hemorrhage	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Nervous system disorders Cerebrovascular accident	1.8% 3/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Nervous system disorders Seizure	1.8% 3/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Nervous system disorders Cerebral infarction	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Nervous system disorders Dizziness	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Nervous system disorders Epilepsy	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Nervous system disorders Headache	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Nervous system disorders Presyncope	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Nervous system disorders Spinal cord compression	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Nervous system disorders Syncope	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Nervous system disorders Vocal cord paralysis	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.8% 3/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Mediastinal hematoma	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Upper airway obstruction	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Metabolism and nutrition disorders Hypercalcemia	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Investigations Platelet count decreased	1.8% 3/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Investigations White blood cell count decreased	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	1.2% 2/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Investigations Neutrophil count decreased	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	1.2% 2/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Musculoskeletal and connective tissue disorders Back pain	1.2% 2/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Cardiac disorders Acute myocardial infarction	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Cardiac disorders Cardiac failure congestive	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Cardiac disorders Myocardial infarction	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Cardiac disorders Tachycardia	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Vascular disorders Hemorrhage	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Vascular disorders Hypertension	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.62% 1/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Vascular disorders Hypotension	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Vascular disorders Orthostatic hypotension	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Vascular disorders Peripheral ischemia	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Immune system disorders Anaphylactic reaction	1.2% 2/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Immune system disorders Immune-mediated adverse reaction	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Injury, poisoning and procedural complications Femoral neck fracture	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Injury, poisoning and procedural complications Spinal compression fracture	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Injury, poisoning and procedural complications Wound secretion	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Renal and urinary disorders Urinary retention	0.00% 0/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	1.2% 2/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Skin and subcutaneous tissue disorders Dermatomyositis	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Hepatobiliary disorders Hepatic failure	0.61% 1/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	0.00% 0/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.

Other adverse events

Measure	Chemo + EBV-CTL n=163 participants at risk gemcitabine+carboplatin + EBV-CTL	Chemo Only n=162 participants at risk gemcitabine+carboplatin
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.1% 10/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	7.4% 12/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.0% 13/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	4.9% 8/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.5% 9/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	6.2% 10/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Anemia	68.1% 111/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	62.3% 101/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Neutropenia	38.7% 63/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	40.1% 65/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Thrombocytopenia	28.8% 47/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	32.1% 52/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Leukopenia	23.9% 39/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	30.2% 49/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Investigations Platelet count decreased	37.4% 61/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	50.0% 81/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Investigations Neutrophil count decreased	36.2% 59/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	40.7% 66/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Investigations White blood cell count decreased	36.8% 60/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	36.4% 59/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Investigations Alanine aminotransferase increased	9.2% 15/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	11.1% 18/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Investigations Aspartate aminotransferase increased	9.8% 16/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	8.0% 13/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Constipation	29.4% 48/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	27.8% 45/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Nausea	14.7% 24/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	19.1% 31/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Diarrhoea	11.0% 18/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	13.0% 21/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Gastrointestinal disorders Vomitting	9.8% 16/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	8.0% 13/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
General disorders Fatigue	22.1% 36/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	23.5% 38/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
General disorders Pyrexia	26.4% 43/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	16.7% 27/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Cough	18.4% 30/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	18.5% 30/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Nervous system disorders Headache	14.1% 23/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	11.1% 18/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Nervous system disorders Dizziness	11.0% 18/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	9.3% 15/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Nervous system disorders Hypoaesthesia	5.5% 9/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	4.9% 8/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Infections and infestations Pneumonia	6.1% 10/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	6.2% 10/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Skin and subcutaneous tissue disorders Pruritis	8.6% 14/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	13.0% 21/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Skin and subcutaneous tissue disorders Rash	9.8% 16/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	11.7% 19/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Musculoskeletal and connective tissue disorders Back pain	11.0% 18/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	8.6% 14/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Metabolism and nutrition disorders Hyponatraemia	14.1% 23/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	9.3% 15/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Metabolism and nutrition disorders Decreased appetite	11.7% 19/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	8.6% 14/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Metabolism and nutrition disorders Hypokalaemia	6.7% 11/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	6.8% 11/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Psychiatric disorders Insomnia	9.2% 15/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	14.2% 23/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Ear and labyrinth disorders Tinnitus	4.9% 8/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	6.8% 11/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.
Musculoskeletal and connective tissue disorders Neck pain	9.8% 16/163 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.	2.5% 4/162 • Adverse events during the entire trial duration were monitored/assessed from randomization to end of treatment (approximately 13 months for Chemo+EBV-CTL and 6 months for Chemo Only). Safety analyses are based on the Safety Analysis Set, defined as all randomized subjects who received at least one dose of study treatment. Subjects were analyzed according to the treatment actually received.

Additional Information

Khong-Bee Kang, Senior Manager Clinical Development

Tessa Therapeutics

Phone: +65 6978 6594

Email: kangkhongbee@tessacell.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place