Trial Outcomes & Findings for Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer (NCT NCT03894891)
NCT ID: NCT03894891
Last Updated: 2023-12-20
Results Overview
LFS defined as time from study registration to earlier of surgical removal of larynx and/or hypopharynx, or death due to any cause. Participants alive with intact larynx and hypopharynx are censored at date of last disease evaluation. Given limited sample size and zero events, the Kaplan-Meier method was not used for estimate of LFS.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Disease was assessed following the completion of 2-3 cycles of induction TPN, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (PD). Participants were followed up to 18.9 months.
Results posted on
2023-12-20
Participant Flow
Enrollment period: December 19, 2019 to November 3, 2020
Participant milestones
| Measure |
Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N
Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1.
Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses).
Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence.
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|---|---|
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Overall Study
STARTED
|
6
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
| Measure |
Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N
Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1.
Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses).
Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Overall Study
Completed protocol treatment per protocol
|
5
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Baseline Characteristics
Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N
n=6 Participants
Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1.
Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses).
Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence.
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|---|---|
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Age, Continuous
|
53.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
|
0 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Disease was assessed following the completion of 2-3 cycles of induction TPN, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (PD). Participants were followed up to 18.9 months.LFS defined as time from study registration to earlier of surgical removal of larynx and/or hypopharynx, or death due to any cause. Participants alive with intact larynx and hypopharynx are censored at date of last disease evaluation. Given limited sample size and zero events, the Kaplan-Meier method was not used for estimate of LFS.
Outcome measures
| Measure |
Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N
n=6 Participants
Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1.
Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses).
Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence.
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|---|---|
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Median Laryngectomy-free Survival (LFS)
|
11.1 months
Interval 1.8 to 18.9
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SECONDARY outcome
Timeframe: Disease evaluation following the completion of the induction phase of treatment on cycle 3 day 43-63.Best radiologic response on treatment was evaluated per RECIST 1.1 criteria. For target lesions: complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Non-CR/Non-PD defined as persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N
n=6 Participants
Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1.
Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses).
Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence.
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|---|---|
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Best Radiologic Response
Complete Response
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3 Participants
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Best Radiologic Response
Partial Response
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2 Participants
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Best Radiologic Response
Non-CR/Non-PD
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1 Participants
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SECONDARY outcome
Timeframe: Participants were observed for OS up to 23.2 months.Overall Survival (OS) is defined as the time from study entry to death or censored at date last known alive. Given limited sample size and zero events, the Kaplan-Meier method was not used for the estimate of OS. The empirical median is provided which represents median time to date last known alive (all 6 participants were censored).
Outcome measures
| Measure |
Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N
n=6 Participants
Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1.
Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses).
Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence.
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|---|---|
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Median Censoring Time for Overall Survival (OS)
|
12.9 months
Interval 2.8 to 23.2
|
SECONDARY outcome
Timeframe: Disease was assessed following the completion of 2-3 cycles of induction TPN, 10-12 weeks after the completion of immunoradiotherapy or surgery and every 3 months until disease progression (PD). Participants were observed for LEDFS up to 18.9 months.LEDFS is defined as time from study registration to earlier of surgical removal of larynx and/or hypopharynx, non-functioning larynx and/or hypopharynx (inability to swallow, speak, and/or breath on own), or death from any cause. Participants alive with intact and functioning larynx and hypopharynx and esophagus are censored at date of last disease evaluation. Given limited sample size and zero events, the Kaplan-Meier method was not used for estimate of LEDFS.
Outcome measures
| Measure |
Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N
n=6 Participants
Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1.
Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses).
Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence.
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|---|---|
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Median Laryngo-esophageal Dysfunction-free Survival (LEDFS)
|
11.1 months
Interval 1.8 to 18.9
|
SECONDARY outcome
Timeframe: At baseline and post IMRT+Nivolumab approximately 22 weeks from start of induction treatment.Population: The evaluable population represents participants with the QLQ-C30 completed at both assessment times.
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. The emotional functional (EF) scale has 3 items (v3 items 21-24). Scores are standardized to range from 0-100. Higher scores indicate better emotional health.
Outcome measures
| Measure |
Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N
n=5 Participants
Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1.
Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses).
Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence.
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|---|---|
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EORTC QLQ-C30 Change in Emotional Functional Score From Baseline to Post IMRT+Nivolumab
|
8.3 units on a scale
Interval -16.7 to 25.0
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SECONDARY outcome
Timeframe: AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort.All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 The number of treated participants experiencing at least one of these adverse events as defined during the time of observation was counted.
Outcome measures
| Measure |
Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N
n=6 Participants
Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1.
Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses).
Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence.
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|---|---|
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Number of Participants With Grade 3-5 Treatment-related Adverse Events
|
3 Participants
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SECONDARY outcome
Timeframe: At baseline and post IMRT+Nivolumab approximately 22 weeks from start of induction treatment.Population: The evaluable population represents participants with the QLQ-C30 completed at both assessment times.
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. The fatigue scale has 3 items (v3 items 10,12,18). Scores are standardized to range from 0-100. Higher scores indicate more symptomatology.
Outcome measures
| Measure |
Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N
n=5 Participants
Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1.
Induction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses).
Participants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence.
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|---|---|
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EORTC QLQ-C30 Change in Fatigue Score From Baseline to Post IMRT+Nivolumab
|
33.3 units on a scale
Interval -33.3 to 66.7
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Adverse Events
Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy
n=6 participants at risk
Docetaxel will be administered per standard institutional every 3 weeks Nivolumab will be administered intravenously every 3 weeks Cisplatin will be administered intravenously every 3 weeks Radioimmunotherapy will be conducted 3 weeks after the last cycle of TPN (docetaxel, cisplatin and nivolumab)
Nivolumab: Nivolumab is a type of immunotherapy that tries to enhance participants own immune system to fight cancer
Cisplatin: Cisplatin is a chemotherapy medication used to treat a number of cancers
Docetaxel: Docetaxel (Taxotere®) is a chemotherapy drug. It is used to treat many types of cancer including head and neck
Radioimmunotherapy: Radiation Therapy to shrink or kill tumors.
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
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|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Serum amylase increased
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
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Other adverse events
| Measure |
Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy
n=6 participants at risk
Docetaxel will be administered per standard institutional every 3 weeks Nivolumab will be administered intravenously every 3 weeks Cisplatin will be administered intravenously every 3 weeks Radioimmunotherapy will be conducted 3 weeks after the last cycle of TPN (docetaxel, cisplatin and nivolumab)
Nivolumab: Nivolumab is a type of immunotherapy that tries to enhance participants own immune system to fight cancer
Cisplatin: Cisplatin is a chemotherapy medication used to treat a number of cancers
Docetaxel: Docetaxel (Taxotere®) is a chemotherapy drug. It is used to treat many types of cancer including head and neck
Radioimmunotherapy: Radiation Therapy to shrink or kill tumors.
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|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Ear and labyrinth disorders
Hearing impaired
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Eye disorders - Other
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Watering eyes
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
4/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dry mouth
|
66.7%
4/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
3/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
3/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Oral pain
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Stomach pain
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema limbs
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fatigue
|
66.7%
4/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Pain
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infections and infestations - Other
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Bruising
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
3/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Creatinine increased
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Investigations - Other
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Platelet count decreased
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Serum amylase increased
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Weight loss
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
White blood cell decreased
|
50.0%
3/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
3/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
33.3%
2/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hot flashes
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort. All-cause mortality was evaluated up to 23.2 months, representing maximum survival for this study cohort.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining AEs regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated in these two subsets of data. 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