Trial Outcomes & Findings for Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer (NCT NCT01932697)
NCT ID: NCT01932697
Last Updated: 2026-02-10
Results Overview
The 2-year loco-regional tumor control (LRC) rate (percentage) is defined as the percentage of patients with no local/regional recurrence or death 2 years after study registration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
2 years
Results posted on
2026-02-10
Participant Flow
Participant milestones
| Measure |
Cohort A (Intermediate Risk)
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
43
|
|
Overall Study
COMPLETED
|
36
|
43
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cohort A (Intermediate Risk)
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
|---|---|---|
|
Overall Study
Received a different amount of tx
|
1
|
0
|
|
Overall Study
Ineligible
|
1
|
0
|
Baseline Characteristics
Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Cohort A (Intermediate Risk)
n=36 Participants
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
n=43 Participants
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
58.9 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
58.7 years
STANDARD_DEVIATION 8.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=4 Participants
|
38 Participants
n=4 Participants
|
71 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=4 Participants
|
43 Participants
n=4 Participants
|
77 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
|
ECOG Performance Status
0
|
34 Participants
n=4 Participants
|
41 Participants
n=4 Participants
|
75 Participants
n=8 Participants
|
|
ECOG Performance Status
1
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe 2-year loco-regional tumor control (LRC) rate (percentage) is defined as the percentage of patients with no local/regional recurrence or death 2 years after study registration.
Outcome measures
| Measure |
Cohort A (Intermediate Risk)
n=36 Participants
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
n=43 Participants
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
Overall (Cohort A + Cohort B)
n=79 Participants
Patients in Cohort A and Cohort B
|
|---|---|---|---|
|
2-year Loco-regional Tumor Control (LRC) Rate
|
100 percentage of patients
|
93 percentage of patients
|
96.2 percentage of patients
|
SECONDARY outcome
Timeframe: 4 months post-hyperfractionated radiation therapyThe overall percentage of patients experiencing grade 3 or higher mucositis oral graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 are reported below.
Outcome measures
| Measure |
Cohort A (Intermediate Risk)
n=36 Participants
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
n=43 Participants
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
Overall (Cohort A + Cohort B)
Patients in Cohort A and Cohort B
|
|---|---|---|---|
|
Incidence of Grade 3 or Higher Mucositis Oral
|
8.3 percentage of patients
|
4.7 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: 2 yearsThe distribution of OS will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Cohort A (Intermediate Risk)
n=36 Participants
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
n=43 Participants
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
Overall (Cohort A + Cohort B)
Patients in Cohort A and Cohort B
|
|---|---|---|---|
|
2-year Overall Survival (OS) Rate
|
100 percentage of patients
|
97.7 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: From registration to the first of either disease recurrence or death, assessed up to 2 yearsThe distribution of PFS will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Cohort A (Intermediate Risk)
n=36 Participants
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
n=43 Participants
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
Overall (Cohort A + Cohort B)
Patients in Cohort A and Cohort B
|
|---|---|---|---|
|
2-year Progression-free Survival (PFS)
|
97.2 percentage of patients
|
86.0 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: 2 yearsThe 2-year Distant metastasis-free survival rate (percentage) is defined as the percentage of patients with no distant recurrence or death 2 years after study registration.
Outcome measures
| Measure |
Cohort A (Intermediate Risk)
n=36 Participants
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
n=43 Participants
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
Overall (Cohort A + Cohort B)
Patients in Cohort A and Cohort B
|
|---|---|---|---|
|
2-year Distant Metastasis-free Survival Rate
|
97.2 percentage of patients
|
88.4 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All patients that completed a Swallow Function assessment at baseline and 12-month post-RT were included. The difference in dose (30 vs 36 Gy) was not expected to have any appreciable difference in toxicity or PRO. What they represented were two different risk groups, hence the need to publish separate cohort disease control metric and why it makes less sense to sort out risk groups for radiation toxicity. It was pre-specified to report this analysis to compare timepoints and not cohorts.
The swallow evaluation consists of a modified barium swallow study(MBS), Functional Oral Intake Scale(FOIS), and Performance Status Scale Head \& Neck(PSS-HN).The 17 swallow questions are rated using a 0 to 5 point scale, with 0 meaning no impairment and 5 max impairment. 6 questions produce a total oral score; scores from 10 questions produce a total pharyngeal score; 1 question produces an esophageal score.The PAS is a validated 8-point scale that ranks the depth of the bolus entry into the airway.A score of 1 indicates no airway entrance;score of 6+ indicate bolus passage past the vocal folds (aspiration).FOIS ranges from 1(nothing by mouth) to 7(total oral diet with no restrictions).PSS-H\&N has 3 components:eating in public(0=always eat alone to 100=no restriction), understandability of speech(0=never understandable, score 100=always understandable), and normalcy of diet(score 0=tube fed to 100=full diet).These scores are summed and normalized to a 0 to 100 scale where 100 is best.
Outcome measures
| Measure |
Cohort A (Intermediate Risk)
n=79 Participants
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
Overall (Cohort A + Cohort B)
Patients in Cohort A and Cohort B
|
|---|---|---|---|
|
Change From Mean Baseline Score to Mean Score at 12 Months Post-RT in Swallow Function as Measured by the Pharyngeal Total Modified Barium Swallow Impairment Profile.
Baseline time point
|
5.57 score on a scale
Interval 0.0 to 15.0
|
—
|
—
|
|
Change From Mean Baseline Score to Mean Score at 12 Months Post-RT in Swallow Function as Measured by the Pharyngeal Total Modified Barium Swallow Impairment Profile.
12 month time point
|
4.48 score on a scale
Interval 0.0 to 14.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All patients treated per protocol and completed the FACT H\&N forms were included in this analysis. The difference in dose (30 vs 36 Gy) was not expected to have any appreciable difference in toxicity or PRO. What they represented were two different risk groups, hence the need to publish separate cohort disease control metric and why it makes less sense to sort out risk groups for radiation toxicity. It was pre-specified to report this analysis to compare timepoints and not cohorts.
The FACT-H\&N is a multidimensional, self-report QOL instrument specifically designed for use with head and neck cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, in addition to 12 site specific items to assess for head and neck related symptoms. Each item is rated on a 0 to 4 type scale where 4 is favorable and 0 unfavorable, and then combined to produce subscale scores for each domain, as well as a global QOL score- with possible score range from 0 to 156. Higher scores represent better QOL.
Outcome measures
| Measure |
Cohort A (Intermediate Risk)
n=68 Participants
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
Overall (Cohort A + Cohort B)
Patients in Cohort A and Cohort B
|
|---|---|---|---|
|
Functional Assessment of Cancer Therapy Head and Neck (FACT H& N) (Version 4)
Baseline
|
117.2 score on a scale
Standard Deviation 17.7
|
—
|
—
|
|
Functional Assessment of Cancer Therapy Head and Neck (FACT H& N) (Version 4)
12 months
|
127.2 score on a scale
Standard Deviation 17.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 year post-treatmentPopulation: All patients treated per protocol and completed the EORTC-QLQ HN35 forms were included in this analysis.
QOL was measured by the European Organization for Research and Treatment for Cancer QOL Questionnaire for Head and Neck Cancer Module 35 (EORTC-QLQ HN35) at baseline and at 1-year post-treatment. Each question scores 0-4, with 0 being favorable and 4 being unfavorable. The average total score at baseline and average total score at 12 months post-RT is reported. The max total score possible is 140(Unfavorable) and the minimum total score possible is 0(Favorable). An increase in score indicates a greater quality of life A paired t-test compares the scores at these two timepoints.
Outcome measures
| Measure |
Cohort A (Intermediate Risk)
n=36 Participants
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
n=43 Participants
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
Overall (Cohort A + Cohort B)
Patients in Cohort A and Cohort B
|
|---|---|---|---|
|
European Organization for Research and Treatment for Cancer QOL Questionnaire for Head and Neck Cancer Module 35 (EORTC-QLQ HN35)
|
106.3 score on a scale
Standard Deviation 10.7
|
111.4 score on a scale
Standard Deviation 9.2
|
—
|
SECONDARY outcome
Timeframe: 1 year post-treatmentPopulation: All patients who were treated per protocol and who completed a EQ-5D-3L were included in this analysis.
QOL was measured by the three-level version of the EuroQol five-dimensional instrument (EQ-5D-3L) at baseline and 1-year post-treatment. This consisted of 5 questions, each score 0 to 3 points with 3 being unfavorable and 0 being favorable. The total possible score per patient per time point is 15 and a minimum score of 0(favorable). The change in average total score at baseline and 12 months post-RT is reported. A paired t-test compares the scores at these two time points. A higher score indicates greater impairment.
Outcome measures
| Measure |
Cohort A (Intermediate Risk)
n=36 Participants
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
n=43 Participants
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
Overall (Cohort A + Cohort B)
Patients in Cohort A and Cohort B
|
|---|---|---|---|
|
EuroQol Five-dimensional Instrument (EQ-5D-3L)
|
6.3 score on a scale
Standard Deviation 1.3
|
5.5 score on a scale
Standard Deviation 0.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 1 week post-radiationThese markers will be correlated with clinical endpoints like acute adverse events, cumulative incidence rates of local/regional failure, overall survival, and disease-free survival.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThese markers will be correlated with clinical endpoints like acute adverse events, cumulative incidence rates of local/regional failure, overall survival, and disease-free survival.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A (Intermediate Risk)
Serious events: 5 serious events
Other events: 38 other events
Deaths: 0 deaths
Cohort B (Extranodal Extension)
Serious events: 5 serious events
Other events: 43 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort A (Intermediate Risk)
n=38 participants at risk
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
n=43 participants at risk
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
|---|---|---|
|
Infections and infestations
Bone infection
|
0.00%
0/38 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
2.3%
1/43 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/38 • Number of events 2 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
0.00%
0/43 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.3%
2/38 • Number of events 2 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
2.3%
1/43 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Gastrointestinal disorders
Oral pain
|
2.6%
1/38 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
0.00%
0/43 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.6%
1/38 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
0.00%
0/43 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Infections and infestations
Lung infection
|
0.00%
0/38 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
2.3%
1/43 • Number of events 2 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/38 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
2.3%
1/43 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
2.6%
1/38 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
0.00%
0/43 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/38 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
2.3%
1/43 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/38 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
2.3%
1/43 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.6%
1/38 • Number of events 2 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
0.00%
0/43 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Vascular disorders
Hypotension
|
0.00%
0/38 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
2.3%
1/43 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Vascular disorders
Lymphedema
|
5.3%
2/38 • Number of events 2 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
0.00%
0/43 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/38 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
2.3%
1/43 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
Other adverse events
| Measure |
Cohort A (Intermediate Risk)
n=38 participants at risk
Patients received 30 Gy delivered in 1.5-Gy fractions twice per day over 2 weeks along with 15 mg/m2 docetaxel once per week.
|
Cohort B (Extranodal Extension)
n=43 participants at risk
Patients with extranodal extension who received the same treatment as Cohort A plus a simultaneous integrated boost to nodal levels with extranodal extension to 36 Gy in 1.8-Gy fractions twice per day.
|
|---|---|---|
|
Investigations
White blood cell decreased
|
2.6%
1/38 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
0.00%
0/43 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/38 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
0.00%
0/43 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
2.6%
1/38 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
0.00%
0/43 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
65.8%
25/38 • Number of events 115 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
72.1%
31/43 • Number of events 109 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/38 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
2.3%
1/43 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Nervous system disorders
Dysgeusia
|
5.3%
2/38 • Number of events 3 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
4.7%
2/43 • Number of events 7 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Nervous system disorders
Stroke
|
2.6%
1/38 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
2.3%
1/43 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/38 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
2.3%
1/43 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Vascular disorders
Lymphedema
|
50.0%
19/38 • Number of events 76 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
60.5%
26/43 • Number of events 97 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Gastrointestinal disorders
Dry mouth
|
97.4%
37/38 • Number of events 259 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
97.7%
42/43 • Number of events 305 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Gastrointestinal disorders
Dysphagia
|
73.7%
28/38 • Number of events 115 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
83.7%
36/43 • Number of events 130 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Gastrointestinal disorders
Esophagitis
|
36.8%
14/38 • Number of events 21 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
34.9%
15/43 • Number of events 25 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Gastrointestinal disorders
Mucositis oral
|
60.5%
23/38 • Number of events 35 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
65.1%
28/43 • Number of events 41 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Gastrointestinal disorders
Nausea
|
47.4%
18/38 • Number of events 25 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
30.2%
13/43 • Number of events 17 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Gastrointestinal disorders
Oral pain
|
52.6%
20/38 • Number of events 36 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
67.4%
29/43 • Number of events 56 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
General disorders
Fatigue
|
89.5%
34/38 • Number of events 164 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
88.4%
38/43 • Number of events 139 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Infections and infestations
Appendicitis
|
2.6%
1/38 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
0.00%
0/43 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.6%
1/38 • Number of events 1 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
0.00%
0/43 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
|
Investigations
Lymphocyte count decreased
|
7.9%
3/38 • Number of events 3 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
2.3%
1/43 • Number of events 2 • 76 months
All patients who received treatment and completed the adverse event form at least once are summarized below.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place