Trial Outcomes & Findings for Evaluation of a New Anti-cancer Immunotherapy in Patients With Non-operable and Progressing Metastatic Cutaneous Melanoma (NCT NCT01213472)

NCT ID: NCT01213472

Last Updated: 2019-10-09

Results Overview

Severe toxicity was defined, according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0), as 1)an Antigen-Specific Cancer Immunotherapeutic (ASCI) related or possibly related Grade 3 or higher toxicity. Grade 3 myalgia, arthralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) should persist for 48 hours despite therapy to be taken into account and as 2)an ASCI related or possibly related Grade 2 or higher allergic reaction occurring within 24 hours of the dose administration.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 33 participants
• Primary outcome timeframe: During the study treatment period (maximum duration = 49 months).
• Results posted on: 2019-10-09

Participant Flow

Among 169 subjects screened, 33 were vaccinated and 6 completed the study. Following the NCT00480025 and NCT00796445 studies, which failed to demonstrate clinical efficacy of the MAGE-A3 antigen-specific cancer immunotherapeutic (ASCI), GSK decided to stop the development of ASCI studies and recruitment in ongoing studies.

Accordingly, patients still on treatment in the study, at the time of protocol amendment 3, either continued until last dose or until recurrence, whichever came first, or until patient or investigator decided to stop study treatment. Therefore, the results summary contain limited primary and secondary endpoints results, and are merely descriptive.

Participant milestones

Measure	NY-ESO 1 Group Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Overall Study STARTED	33
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	NY-ESO 1 Group Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Overall Study Recurrence/Progressive disease	25
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Baseline Characteristics

Evaluation of a New Anti-cancer Immunotherapy in Patients With Non-operable and Progressing Metastatic Cutaneous Melanoma

Baseline characteristics by cohort

Measure	NY-ESO 1 Group n=33 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Age, Continuous	65.7 Years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the study treatment period (maximum duration = 49 months).

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

Severe toxicity was defined, according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0), as 1)an Antigen-Specific Cancer Immunotherapeutic (ASCI) related or possibly related Grade 3 or higher toxicity. Grade 3 myalgia, arthralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) should persist for 48 hours despite therapy to be taken into account and as 2)an ASCI related or possibly related Grade 2 or higher allergic reaction occurring within 24 hours of the dose administration.

Outcome measures

Measure	NY-ESO 1 Group n=33 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Number of Patients With Severe Toxicities During the Study Treatment Period	0 Participants

PRIMARY outcome

Timeframe: During the one year follow-up period (i.e. from Month 49 until Month 61)

Population: The analysis was to be performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the ASCI treatment. All active follow-up visits and procedures were stopped, hence this follow-up analysis was not performed as initially planned.

Severe toxicity was defined, according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0), as 1)an Antigen-Specific Cancer Immunotherapeutic (ASCI) related or possibly related Grade 3 or higher toxicity. Grade 3 myalgia, arthralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) should persist for 48 hours despite therapy in order to be taken into account and as 2)an ASCI related or possibly related Grade 2 or higher allergic reaction occurring within 24 hours of the dose administration. All active follow-up visits and procedures were stopped, hence this follow-up analysis was not performed as initially planned.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: During the study treatment period (maximum duration = 49 months).

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

Best response was recorded from the start of treatment until disease progression. Response assessment was essentially based on a set of measurable lesions (target lesions [TL]), and any other lesions (non-target lesions [NTL]), both identified at baseline. Complete Response (CR)=disappearance of all TL or NTL; Partial Response (PR) = at least 30 percent (%) decrease in the sum of the longest diameter(LD) of TL compared to baseline, stable disease (SD) = neither sufficient shrinkage to qualify PR nor sufficient increase to qualify for Progressive disease (PD) compared with baseline; PD = at least 20% increase in the sum of LD of TL compared with baseline, or the appearance of one or more new lesions, or both of these, and/or unequivocal progression of existing NTL; NE =non-evaluable; Clinical response: any CR or PR best overall response; Disease control: any CR, PR, SD or SD/PR best overall response.

Outcome measures

Measure	NY-ESO 1 Group n=33 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Number of Patients With the Best Overall Response in the Overall Population Best response, CR	3 Participants
Number of Patients With the Best Overall Response in the Overall Population Best response, PR	2 Participants
Number of Patients With the Best Overall Response in the Overall Population Best response, SD	2 Participants
Number of Patients With the Best Overall Response in the Overall Population Best response, SD/PR	2 Participants
Number of Patients With the Best Overall Response in the Overall Population Best response, PD	23 Participants
Number of Patients With the Best Overall Response in the Overall Population Best response, NE	1 Participants
Number of Patients With the Best Overall Response in the Overall Population Clinical Response, Yes	5 Participants
Number of Patients With the Best Overall Response in the Overall Population Clinical Response, No	28 Participants
Number of Patients With the Best Overall Response in the Overall Population Disease control, Yes	9 Participants
Number of Patients With the Best Overall Response in the Overall Population Disease control, No	24 Participants

SECONDARY outcome

Timeframe: During the study treatment period (maximum duration = 49 months).

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

Patients with Slow Progressive Disease (SPD) status met the following criteria: patient's Eastern Cooperative Oncology Group (ECOG) performance status was 0 or 1, patient's lactate dehydrogenase (LDH) value was not greater than twice the normal upper limit, there was no appearance of visceral metastases other than in the lung, patients did not meet any of the criteria for permanent stopping of study treatment. Mixed response (MxR) criteria was defined as follows: at least 30% decrease in the longest diameter (LD) occurring in at least one target lesion recorded and measured at baseline. Such response occurring in otherwise stable disease (SD) or progressive disease (PD) status of LD of target lesions and without the appearance of one or more new lesions were classified as "SD with target lesion regression" or "PD with target lesion regression". The appearance of new lesions in otherwise partial response (PR) status of the LD of target lesions were classified as "PR with new lesion".

Outcome measures

Measure	NY-ESO 1 Group n=33 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Number of Patients With Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria CR	3 Participants
Number of Patients With Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria PR	2 Participants
Number of Patients With Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria SD/PR	2 Participants
Number of Patients With Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria MxR: SD with target lesion regression	0 Participants
Number of Patients With Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria MxR: PD with target lesion regression	3 Participants
Number of Patients With Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria MxR: PR with new lesion	2 Participants
Number of Patients With Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria SD without mixed response	2 Participants
Number of Patients With Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria PD with SPD criteria	10 Participants
Number of Patients With Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria PD without SPD/MxR	8 Participants
Number of Patients With Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria NE	1 Participants

SECONDARY outcome

Timeframe: After 12, 22, 31 and 54 weeks of treatment.

Population: As study development was stopped earlier and decision was taken not to perform further testing on biological samples already collected, except if a scientific rationale remained relevant, analyses for patients who presented MAGE-A3 gene signature as required in this outcome, were not performed.

Following MAGE3-AS15-NSC-003 (ADJ) (NCT00480025) study (A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 Antigen-Specific Cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive Non-Small Cell Lung Cancer) showed the absence of treatment effect in any of the primary, secondary, or exploratory analyses, clinical activity was not reported within the population of patients who present the predictive MAGE-A3 gene signature, in that study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the study treatment period (maximum duration = 49 months).

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

An AE is any untoward medical occurrence in a clinical investigation patient, temporally associated with the use of a medical product, whether or not considered related to the medicinal product. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack efficacy), abuse or misuse.

Outcome measures

Measure	NY-ESO 1 Group n=33 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Number of Patients With Adverse Events (AEs) by Maximum Grade Any event, Grade 1	9 Participants
Number of Patients With Adverse Events (AEs) by Maximum Grade Any event, Grade 2	21 Participants
Number of Patients With Adverse Events (AEs) by Maximum Grade Any event, Grade 3	3 Participants
Number of Patients With Adverse Events (AEs) by Maximum Grade Any event, Grade 4	0 Participants
Number of Patients With Adverse Events (AEs) by Maximum Grade Any event, Grade 5	0 Participants

SECONDARY outcome

Timeframe: During the study treatment period (maximum duration = 49 months).

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

An AE is any untoward medical occurrence in a clinical investigation patient, temporally associated with the use of a medical product, whether or not considered related to the medicinal product. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack efficacy), abuse or misuse.

Outcome measures

Measure	NY-ESO 1 Group n=33 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Number of Patients With Adverse Events (AEs) That Are Causally Related to Treatment Administration by Maximum Grade Any event, Grade 4	0 Participants
Number of Patients With Adverse Events (AEs) That Are Causally Related to Treatment Administration by Maximum Grade Any event, Grade 5	0 Participants
Number of Patients With Adverse Events (AEs) That Are Causally Related to Treatment Administration by Maximum Grade Any event, Grade 1	20 Participants
Number of Patients With Adverse Events (AEs) That Are Causally Related to Treatment Administration by Maximum Grade Any event, Grade 2	13 Participants
Number of Patients With Adverse Events (AEs) That Are Causally Related to Treatment Administration by Maximum Grade Any event, Grade 3	0 Participants

SECONDARY outcome

Timeframe: During the study treatment period (maximum duration = 49 months).

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient, is a grade 4 AE according to the Common Terminology Criteria for Adverse Events (CTCAE, v 4.0), in addition, in this study, Grade 3 or higher pIMDs were considered as medically significant and were therefore notified as SAE.

Outcome measures

Measure	NY-ESO 1 Group n=33 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Number of Patients With Serious Adverse Events (SAEs) by Maximum Grade Any event, Grade 1	0 Participants
Number of Patients With Serious Adverse Events (SAEs) by Maximum Grade Any event, Grade 2	1 Participants
Number of Patients With Serious Adverse Events (SAEs) by Maximum Grade Any event, Grade 3	2 Participants
Number of Patients With Serious Adverse Events (SAEs) by Maximum Grade Any event, Grade 4	0 Participants
Number of Patients With Serious Adverse Events (SAEs) by Maximum Grade Any event, Grade 5	0 Participants

SECONDARY outcome

Timeframe: During the study treatment period (maximum duration = 49 months).

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient, is a grade 4 AE according to the Common Terminology Criteria for Adverse Events (CTCAE, v 4.0), in addition, in this study, Grade 3 or higher pIMDs will be considered as medically significant and will therefore be notified as SAE. No serious adverse events were reported during the study period that are causally related to treatment administration by maximum grade.

Outcome measures

Measure	NY-ESO 1 Group n=33 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Number of Patients With Serious Adverse Events (SAEs) That Are Causally Related to Treatment Administration by Maximum Grade	0 Participants

SECONDARY outcome

Timeframe: From first treatment administration (i.e. at Week 0) until the last treatment administration (i.e. at Month 48)

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

Time to Treatment Failure (TTF) was defined as the time from first treatment until the date of the last treatment administration, for patients who discontinued the treatment prematurely, regardless of the reason for study treatment discontinuation. Patients who completed their full treatment phase or who were still on treatment at the time of analysis were censored on their last study treatment administration date..

Outcome measures

Measure	NY-ESO 1 Group n=33 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Time to Treatment Failure (TTF)	4.7 Months Interval 3.3 to 11.7

SECONDARY outcome

Timeframe: From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

Progression-free survival (PFS) was defined as the time from first treatment to either the date of first disease progression (PD) or the date of death (for whatever reason), whichever came first. Patients alive and without disease progression were censored at the date of the last visit/contact.

Outcome measures

Measure	NY-ESO 1 Group n=33 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Progression-free Survival (PFS) Rate	2.8 Months Interval 2.8 to 2.9

SECONDARY outcome

Timeframe: From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

Overall survival (OS) was defined as the time from first treatment until death. Patients alive at the time of analysis were censored at the time of last visit/contact.

Outcome measures

Measure	NY-ESO 1 Group n=33 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Overall Survival (OS)	NA Months The median was not reached at the time of the analysis.

SECONDARY outcome

Timeframe: From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)

Population: As study development was stopped earlier and decision was taken not to perform further testing on biological samples already collected, except if a scientific rationale remained relevant, analyses on Duration of Response for Patients With CR, PR or SD Status, as required in this outcome, were not performed.

The duration of response was measured from the time when the measurement criteria for CR/PR (whichever was recorded first) or SD evaluation were met until the first date that first PD or death was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the sum of LD of target lesions recorded previously but not necessarily at baseline (The minimal time interval required between two measurements for determination of SD was at least 16 weeks.). The analysis was not performed as initially planned.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

Progression-free survival was defined as the time from the date of registration of the patient to either the date of disease progression or the date of death (for whatever reason), whichever came first. Patients alive and without disease progression were censored at the date of their last tumor evaluation. PFS events included progressive disease (PD), death in absence of PD and events (Any event which was part of the natural course of the disease under study, was captured as an efficacy measure. Therefore it did not need to be reported as an SAE).

Outcome measures

Measure	NY-ESO 1 Group n=33 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Number of Patients With Progression-free Survival Events PD, Yes	29 Participants
Number of Patients With Progression-free Survival Events PD, No	4 Participants
Number of Patients With Progression-free Survival Events Death in absence of PD, Yes	0 Participants
Number of Patients With Progression-free Survival Events Death in absence of PD, No	33 Participants
Number of Patients With Progression-free Survival Events Events, Yes	29 Participants
Number of Patients With Progression-free Survival Events Events, No	4 Participants

SECONDARY outcome

Timeframe: During the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.]

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

Summary of deaths included death, autopsy performed and cause of death. Progression of the tumor was recorded in the clinical assessments. Death due to progressive disease was to be recorded on a specific form in the case report form but not as a serious adverse event (SAE). However, if the investigator considered that there was a causal relationship between the administration of the treatment or protocol design/procedures and the disease progression, then this must be reported as an SAE.

Outcome measures

Measure	NY-ESO 1 Group n=33 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Summary of Deaths Related to Progressive Disease of Cancer Under Study Reported After the Study Treatment, in the Period of Long-term Follow-up for Survival Autopsy performed, Unknown	2 Participants
Summary of Deaths Related to Progressive Disease of Cancer Under Study Reported After the Study Treatment, in the Period of Long-term Follow-up for Survival Autopsy performed, Yes	0 Participants
Summary of Deaths Related to Progressive Disease of Cancer Under Study Reported After the Study Treatment, in the Period of Long-term Follow-up for Survival Autopsy performed, No	6 Participants
Summary of Deaths Related to Progressive Disease of Cancer Under Study Reported After the Study Treatment, in the Period of Long-term Follow-up for Survival Death, Yes	8 Participants
Summary of Deaths Related to Progressive Disease of Cancer Under Study Reported After the Study Treatment, in the Period of Long-term Follow-up for Survival Death, No	25 Participants
Summary of Deaths Related to Progressive Disease of Cancer Under Study Reported After the Study Treatment, in the Period of Long-term Follow-up for Survival Cause of death, Disease under study (melanoma)	8 Participants

SECONDARY outcome

Timeframe: Before treatment (PRE), at 4 (W4), 8 (W8), 10 (W10), 12 (W12), 29 (W29), 51 (W51), 75 (W75), 99 (W99), 123 (W123) weeks of treatment and at the concluding visit, i.e. at Month 49 (POST)

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

Anti-NY-ESO-1 antibody concentrations were presented as geometric mean concentrations (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Measure	NY-ESO 1 Group n=27 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Anti NY-ESO-1 Antibody Concentrations PRE	179.7 EL.U/mL Interval 100.8 to 320.3
Anti NY-ESO-1 Antibody Concentrations W4	4134.0 EL.U/mL Interval 2250.9 to 7592.3
Anti NY-ESO-1 Antibody Concentrations W8	15235.4 EL.U/mL Interval 9762.1 to 23777.2
Anti NY-ESO-1 Antibody Concentrations W10	22373.0 EL.U/mL Interval 15198.4 to 32934.5
Anti NY-ESO-1 Antibody Concentrations W12	25626.1 EL.U/mL Interval 16866.9 to 38934.0
Anti NY-ESO-1 Antibody Concentrations W29	30684.5 EL.U/mL Interval 22913.5 to 41091.2
Anti NY-ESO-1 Antibody Concentrations W51	23393.6 EL.U/mL Interval 16574.2 to 33018.9
Anti NY-ESO-1 Antibody Concentrations W75	12661.4 EL.U/mL Interval 8063.2 to 19881.9
Anti NY-ESO-1 Antibody Concentrations W99	10313.6 EL.U/mL Interval 3389.6 to 31381.9
Anti NY-ESO-1 Antibody Concentrations W123	5878.2 EL.U/mL Interval 1460.4 to 23659.5
Anti NY-ESO-1 Antibody Concentrations POST	17775.8 EL.U/mL Interval 10390.0 to 30411.8

SECONDARY outcome

Timeframe: At 4 (W4), 8 (W8), 10 (W10), 12 (W12), 29 (W29), 51 (W51), 75 (W75), 99 (W99), 123 (W123) weeks of treatment and at the concluding visit, i.e. at Month 49 (POST)

Population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

Anti NY-ESO-1 antibody response was defined as: For initially seronegative patients: post-vaccination antibody concentration greater than or equal to (≥) 179 EU/mL and for intially seropositive patients: post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.

Outcome measures

Measure	NY-ESO 1 Group n=26 Participants Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Humoral Response for Anti NY-ESO-1 Antibodies W4	24 Participants
Humoral Response for Anti NY-ESO-1 Antibodies W8	21 Participants
Humoral Response for Anti NY-ESO-1 Antibodies W10	23 Participants
Humoral Response for Anti NY-ESO-1 Antibodies W12	19 Participants
Humoral Response for Anti NY-ESO-1 Antibodies W29	13 Participants
Humoral Response for Anti NY-ESO-1 Antibodies W51	6 Participants
Humoral Response for Anti NY-ESO-1 Antibodies W75	3 Participants
Humoral Response for Anti NY-ESO-1 Antibodies W99	1 Participants
Humoral Response for Anti NY-ESO-1 Antibodies W123	0 Participants
Humoral Response for Anti NY-ESO-1 Antibodies POST	9 Participants

SECONDARY outcome

Timeframe: Before treatment (PRE), at 4 (W4), 8 (W8), 10 (W10), 12 (W12), 29 (W29), 51 (W51), 75 (W75), 99 (W99), 123 (W123) weeks of treatment and at the concluding visit, i.e. at Month 49 (POST)

Population: As study development was stopped earlier, and decision was taken not to perform further testing on biological samples already collected, except if a scientific rationale remained relevant, Cellular (T-cell) response was not analysed as data only available for few patients.

Cellular (T-cell) response was not analysed as data only available for few patients.

Outcome measures

Outcome data not reported

Adverse Events

NY-ESO 1 Group

Serious events: 3 serious events

Other events: 33 other events

Deaths: 8 deaths

Serious adverse events

Measure	NY-ESO 1 Group n=33 participants at risk Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Blood and lymphatic system disorders Anaemia	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Postoperative wound infection	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Musculoskeletal and connective tissue disorders Back pain	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Reproductive system and breast disorders Uterine cyst	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.

Other adverse events

Measure	NY-ESO 1 Group n=33 participants at risk Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
Blood and lymphatic system disorders Anaemia	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Cardiac disorders Arrhythmia	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Cardiac disorders Tachycardia	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Ear and labyrinth disorders Vertigo	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Eye disorders Periorbital oedema	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Gastrointestinal disorders Abdominal pain	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Gastrointestinal disorders Abdominal pain upper	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Gastrointestinal disorders Anal fissure	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Gastrointestinal disorders Constipation	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Gastrointestinal disorders Dental caries	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Gastrointestinal disorders Diarrhoea	15.2% 5/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Gastrointestinal disorders Gastroesophageal reflux disease	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Gastrointestinal disorders Nausea	27.3% 9/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Gastrointestinal disorders Oral pain	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Gastrointestinal disorders Toothache	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Gastrointestinal disorders Vomiting	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Administration site rash	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Asthenia	18.2% 6/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Chills	15.2% 5/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Fatigue	45.5% 15/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Impaired healing	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Inflammation	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Influenza like illness	45.5% 15/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Injection site erythema	18.2% 6/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Injection site induration	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Injection site inflammation	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Injection site oedema	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Injection site pain	66.7% 22/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Injection site pruritus	9.1% 3/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Injection site reaction	18.2% 6/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Injection site swelling	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Malaise	9.1% 3/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Oedema peripheral	9.1% 3/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Pain	15.2% 5/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Pyrexia	39.4% 13/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
General disorders Swelling	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Immune system disorders Hypersensitivity	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Bronchitis	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Conjunctivitis	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Cystitis	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Erysipelas	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Infection	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Influenza	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Nasopharyngitis	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Oral viral infection	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Pneumonia	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Sinusitis	9.1% 3/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Tinea infection	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Upper respiratory tract infection	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Urinary tract infection	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Viral infection	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Infections and infestations Wound infection	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Injury, poisoning and procedural complications Bone contusion	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Injury, poisoning and procedural complications Graft complication	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Injury, poisoning and procedural complications Muscle strain	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Injury, poisoning and procedural complications Skin abrasion	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Investigations Blood pressure decreased	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Investigations Gamma-glutamyltransferase increased	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Investigations Weight decreased	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Metabolism and nutrition disorders Decreased appetite	18.2% 6/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Musculoskeletal and connective tissue disorders Arthralgia	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Musculoskeletal and connective tissue disorders Back pain	15.2% 5/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Musculoskeletal and connective tissue disorders Jaw cyst	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Musculoskeletal and connective tissue disorders Muscle spasms	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Musculoskeletal and connective tissue disorders Myalgia	18.2% 6/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Musculoskeletal and connective tissue disorders Neck pain	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 3/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor haemorrhage	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor ulceration	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Nervous system disorders Disturbance in attention	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Nervous system disorders Dizziness	9.1% 3/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Nervous system disorders Dysgeusia	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Nervous system disorders Headache	33.3% 11/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Nervous system disorders Hypersomnia	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Nervous system disorders Lethargy	12.1% 4/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Nervous system disorders Neuropathy peripheral	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Nervous system disorders Paraesthesia	9.1% 3/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Nervous system disorders Sciatica	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Psychiatric disorders Depression	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Psychiatric disorders Insomnia	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Psychiatric disorders Irritability	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Renal and urinary disorders Chronic kidney disease	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Renal and urinary disorders Dysuria	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Renal and urinary disorders Haematuria	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Reproductive system and breast disorders Cervical polyp	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Reproductive system and breast disorders Uterine cyst	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Respiratory, thoracic and mediastinal disorders Cough	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Skin and subcutaneous tissue disorders Actinic keratosis	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Skin and subcutaneous tissue disorders Dry skin	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Skin and subcutaneous tissue disorders Erythema	9.1% 3/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Skin and subcutaneous tissue disorders Night sweats	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Skin and subcutaneous tissue disorders Pruritus	12.1% 4/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Skin and subcutaneous tissue disorders Rash erythematous	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Skin and subcutaneous tissue disorders Vitiligo	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Vascular disorders Hyperaemia	3.0% 1/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Vascular disorders Hypertension	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.
Vascular disorders Lymphoedema	6.1% 2/33 • AEs and SAEs were collected during the study treatment period, i.e. from Month 0 to Month 49 (maximum treatment duration) in the overall population. All-Cause Mortality events were collected during the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.] As planned per study protocol, any event which was part of the natural course of the disease under study was captured as an efficacy measure (i.e.: Progression of the tumor and death due to progressive disease) and did not need to be reported as an SAE or fatal SAE. However, if the investigator considered that there was a causal relationship between the administration of the ASCI or protocol design/procedures and the disease progression, then this was reported as an SAE.

Additional Information

GSK Clinical Trials

GlaxoSmithKline

Phone: 877-379-3718

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

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

Restriction type: OTHER