Trial Outcomes & Findings for A Phase II Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma (NCT NCT00834093)
NCT ID: NCT00834093
Last Updated: 2023-06-28
Results Overview
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Restaging scans were performed every 8 weeks on treatment up to 20 weeks.
Results posted on
2023-06-28
Participant Flow
Participants enrolled from April 2009 to July 2011.
Participant milestones
| Measure |
EBV-stimulated Cytotoxic T-lymphocyte (EBV-CTL) Immunotherapy
Eligible participants underwent a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated preparation time 14-16 weeks\]. Participants received palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Participants who achieved a partial response or better while receiving palliative chemotherapy continued to receive chemotherapy for 3 to 6 cycles and were only eligible for immunotherapy when progressive disease (PD) was confirmed. Each participant received a minimum of 2 EBV-CTL infusions, given 2 weeks apart, at doses of 1x108 cells/m2. A 3rd infusion was offered to participants 8-12 weeks after the 2nd infusion based on response, tolerability and sufficient immunotherapy product reserves.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
Eligible and Treated
|
13
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
EBV-stimulated Cytotoxic T-lymphocyte (EBV-CTL) Immunotherapy
Eligible participants underwent a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated preparation time 14-16 weeks\]. Participants received palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Participants who achieved a partial response or better while receiving palliative chemotherapy continued to receive chemotherapy for 3 to 6 cycles and were only eligible for immunotherapy when progressive disease (PD) was confirmed. Each participant received a minimum of 2 EBV-CTL infusions, given 2 weeks apart, at doses of 1x108 cells/m2. A 3rd infusion was offered to participants 8-12 weeks after the 2nd infusion based on response, tolerability and sufficient immunotherapy product reserves.
|
|---|---|
|
Overall Study
Progressive Disease
|
3
|
|
Overall Study
Withdrawal by subject or MD Decision
|
5
|
Baseline Characteristics
A Phase II Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
Baseline characteristics by cohort
| Measure |
EBV-stimulated Cytotoxic T-lymphocyte (EBV-CTL) Immunotherapy
n=18 Participants
Eligible participants underwent a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated preparation time 14-16 weeks\]. Participants received palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Participants who achieved a partial response or better while receiving palliative chemotherapy continued to receive chemotherapy for 3 to 6 cycles and were only eligible for immunotherapy when progressive disease (PD) was confirmed. Each participant received a minimum of 2 EBV-CTL infusions, given 2 weeks apart, at doses of 1x108 cells/m2. A 3rd infusion was offered to participants 8-12 weeks after the 2nd infusion based on response, tolerability and sufficient immunotherapy product reserves.
|
|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Restaging scans were performed every 8 weeks on treatment up to 20 weeks.Population: The analysis dataset is comprised of eligible and treated participants.
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Outcome measures
| Measure |
EBV-stimulated Cytotoxic T-lymphocyte (EBV-CTL) Immunotherapy
n=13 Participants
Eligible participants undergo a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated time 14-16 weeks\]. Participants receive palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Each participant receives a minimum of 2 T-cell product infusions, given 2 weeks apart. A 3rd infusion may be given 8-12 weeks later based on response, tolerability and sufficient immunotherapy product reserves.Eligible participants underwent a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated preparation time 14-16 weeks\]. Participants received palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Participants who achieved a partial response or better while receiving palliative chemotherapy continued to receive chemotherapy for 3 to 6 cycles and were only eligible for immunotherapy when progressive disease (PD) was confirmed. Each participant received a minimum of 2 EBV-CTL infusions, given 2 weeks apart, at doses of 1x108 cells/m2. A 3rd infusion was offered to participants 8-12 weeks after the 2nd infusion based on response, tolerability and sufficient immunotherapy product reserves.
|
|---|---|
|
Best Overall Response Rate (ORR)
|
0.0 percentage of participants
Interval 0.0 to 20.6
|
SECONDARY outcome
Timeframe: Restaging scans were performed every 8 weeks until PD. Follow-up duration was up to 92 months.Population: The analysis dataset is comprised of eligible and treated participants.
TTP estimated using the Kaplan-Meier method is defined as the duration of time from registration to documented first observation of progressive disease (PD), or censored at date last known progression-free. Based on RECIST 1.1, radiographic PD is defined as at least a 20% increase in the sum of the longest diameter (LD) for all target lesions (up to 10), taking as reference the smallest sum LD since beginning treatment or the appearance of one or more new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing lesions.
Outcome measures
| Measure |
EBV-stimulated Cytotoxic T-lymphocyte (EBV-CTL) Immunotherapy
n=13 Participants
Eligible participants undergo a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated time 14-16 weeks\]. Participants receive palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Each participant receives a minimum of 2 T-cell product infusions, given 2 weeks apart. A 3rd infusion may be given 8-12 weeks later based on response, tolerability and sufficient immunotherapy product reserves.Eligible participants underwent a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated preparation time 14-16 weeks\]. Participants received palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Participants who achieved a partial response or better while receiving palliative chemotherapy continued to receive chemotherapy for 3 to 6 cycles and were only eligible for immunotherapy when progressive disease (PD) was confirmed. Each participant received a minimum of 2 EBV-CTL infusions, given 2 weeks apart, at doses of 1x108 cells/m2. A 3rd infusion was offered to participants 8-12 weeks after the 2nd infusion based on response, tolerability and sufficient immunotherapy product reserves.
|
|---|---|
|
Time to Progression (TTP)
|
7.9 months
Interval 6.7 to 9.9
|
SECONDARY outcome
Timeframe: Adverse events were assessed after each infusion treatment. Treatment duration was up to 66 months.Population: The analysis dataset is comprised of eligible and treated participants.
All grade 1-2 fatigue adverse events (AE) with any treatment attribution as reported on case report forms were counted. The number of participants experiencing at least one grade 1-2 fatigue AE during the time of observation.
Outcome measures
| Measure |
EBV-stimulated Cytotoxic T-lymphocyte (EBV-CTL) Immunotherapy
n=13 Participants
Eligible participants undergo a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated time 14-16 weeks\]. Participants receive palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Each participant receives a minimum of 2 T-cell product infusions, given 2 weeks apart. A 3rd infusion may be given 8-12 weeks later based on response, tolerability and sufficient immunotherapy product reserves.Eligible participants underwent a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated preparation time 14-16 weeks\]. Participants received palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Participants who achieved a partial response or better while receiving palliative chemotherapy continued to receive chemotherapy for 3 to 6 cycles and were only eligible for immunotherapy when progressive disease (PD) was confirmed. Each participant received a minimum of 2 EBV-CTL infusions, given 2 weeks apart, at doses of 1x108 cells/m2. A 3rd infusion was offered to participants 8-12 weeks after the 2nd infusion based on response, tolerability and sufficient immunotherapy product reserves.
|
|---|---|
|
Number of Participants With Grade 1-2 Fatigue Adverse Events," as Accurate and Appropriate
|
9 Participants
|
SECONDARY outcome
Timeframe: Participants were followed for survival per institutional practice until death or lost-to-follow-up. Follow-up duration was up to 92 months.Population: The analysis dataset is comprised of eligible and treated participants.
OS estimated using the Kaplan-Meier (KM) method is defined as the time from registration to death, or censored at the date last known alive.
Outcome measures
| Measure |
EBV-stimulated Cytotoxic T-lymphocyte (EBV-CTL) Immunotherapy
n=13 Participants
Eligible participants undergo a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated time 14-16 weeks\]. Participants receive palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Each participant receives a minimum of 2 T-cell product infusions, given 2 weeks apart. A 3rd infusion may be given 8-12 weeks later based on response, tolerability and sufficient immunotherapy product reserves.Eligible participants underwent a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated preparation time 14-16 weeks\]. Participants received palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Participants who achieved a partial response or better while receiving palliative chemotherapy continued to receive chemotherapy for 3 to 6 cycles and were only eligible for immunotherapy when progressive disease (PD) was confirmed. Each participant received a minimum of 2 EBV-CTL infusions, given 2 weeks apart, at doses of 1x108 cells/m2. A 3rd infusion was offered to participants 8-12 weeks after the 2nd infusion based on response, tolerability and sufficient immunotherapy product reserves.
|
|---|---|
|
Overall Survival (OS)
|
25.0 months
Interval 6.0 to 28.2
|
Adverse Events
EBV-stimulated Cytotoxic T-lymphocyte (EBV-CTL) Immunotherapy
Serious events: 0 serious events
Other events: 13 other events
Deaths: 8 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EBV-stimulated Cytotoxic T-lymphocyte (EBV-CTL) Immunotherapy
n=13 participants at risk
Eligible participants undergo a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated time 14-16 weeks\]. Participants receive palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Each participant receives a minimum of 2 T-cell product infusions, given 2 weeks apart. A 3rd infusion may be given 8-12 weeks later based on response, tolerability and sufficient immunotherapy product reserves.Eligible participants underwent a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated preparation time 14-16 weeks\]. Participants received palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Participants who achieved a partial response or better while receiving palliative chemotherapy continued to receive chemotherapy for 3 to 6 cycles and were only eligible for immunotherapy when progressive disease (PD) was confirmed. Each participant received a minimum of 2 EBV-CTL infusions, given 2 weeks apart, at doses of 1x108 cells/m2. A 3rd infusion was offered to participants 8-12 weeks after the 2nd infusion based on response, tolerability and sufficient immunotherapy product reserves.
|
|---|---|
|
Infections and infestations
Infection w/ unk ANC conjunctiva
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Ear and labyrinth disorders
Otitis, external ear (non-infectious)
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Ocular-other
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Constipation
|
30.8%
4/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dry mouth
|
23.1%
3/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dysphagia
|
15.4%
2/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Abdomen, pain
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dental/teeth/peridontal, pain
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Stomach, pain
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fatigue
|
69.2%
9/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Constitutional, other
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Pain-other
|
38.5%
5/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Flu-like syndrome
|
15.4%
2/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, sinus
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection-other
|
15.4%
2/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
46.2%
6/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Taste disturbance
|
15.4%
2/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neuropathy-sensory
|
38.5%
5/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neurologic-other
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Head/headache
|
15.4%
2/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage NOS
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
23.1%
3/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
15.4%
2/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Serious Adverse Events and Other Adverse Events were assessed throughout the treatment duration for up to 66 months. All-Cause Mortality was monitored until death or when lost-to-follow-up, for up to 92 months.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place