Trial Outcomes & Findings for Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer (NCT NCT03107182)
NCT ID: NCT03107182
Last Updated: 2025-05-06
Results Overview
DRR is defined as ≥50% tumor shrinkage by RECIST 1.1. We will evaluate the overall percentage of patients treated with dose-reduced radiotherapy or TORS to determine the tumor shrinkage based on treatment received.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
24 months
Results posted on
2025-05-06
Participant Flow
Participant milestones
| Measure |
Single Modality De-escalation Arm (SDA)
Patients with low risk, who do not qualify for TORS (due to volume of disease or poor visualization/access) or refuse TORS, who have ≥50% reduction by RECIST following induction chemotherapy will be given de-intensified treatment with radiation alone to 50 G.
Nivolumab: All enrolled patients will receive three 21-day cycles of nivolumab (360 mg on days 1; 3 doses total).
Adjuvant nivolumab will be offered to all patients for 6-months post completion of locoregional therapy for a total of 7 doses.
Transoral robotic surgery (TORS): Patients with low risk and small volume tonsillar disease (T1-T2, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) or base of tongue disease (T1-2 with lateralized primary ≤3 cm, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) who have ≥50% reduction by RECIST following induction chemotherapy will undergo TORS and selective nodal dissection. Patients may refuse TORS treatment. Patients will receive RT or TORS.
Adjuvant RT: Patients with low risk, who do not qualify for TORS (due to volume of disease or poor visualization/access) or refuse TORS, who have ≥50% reduction by RECIST following induction chemotherapy will be given de-intensified treatment with radiation alone to 50 Gy. Patients will receive RT or TORS.
|
Intermediate De-escalation Arm (IDA)
Patients who have high risk disease and ≥50% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 50 Gy with concurrent bolus cisplatin (x2 doses) or TFHX to 45 Gy (3 cycles).
|
Regular Dose Arm (RDA)
Following the induction treatments (carboplatin, nab-paclitaxel, and nivolumab), patients will be assessed based on response to chemotherapy and high or low risk status.
Patients who have low risk disease and \<30% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX (paclitaxel, 5-FU, hydroxyurea, dexamethasone, famotidine, and diphenhydramine) to 75 Gy (5 cycles).
Patients who have high risk disease and \<50% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX to 75 Gy (5 cycles).
Any patient who has progressive disease will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX to 75 Gy (5 cycles).
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
34
|
10
|
|
Overall Study
COMPLETED
|
28
|
34
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Single Modality De-escalation Arm (SDA)
n=28 Participants
Radiation alone or transoral robotic surgery.
|
Intermediate De-escalation Arm (IDA)
n=34 Participants
TFHX (paclitaxel (100mg/m2 on day 1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle )or cisplatin.
|
Regular Dose Arm (RDA)
n=10 Participants
Regular dose chemoradiotherapy and TFHX (paclitaxel (100mg/m2 on day 1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle )or cisplatin.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
34 participants
n=7 Participants
|
10 participants
n=5 Participants
|
72 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 monthsDRR is defined as ≥50% tumor shrinkage by RECIST 1.1. We will evaluate the overall percentage of patients treated with dose-reduced radiotherapy or TORS to determine the tumor shrinkage based on treatment received.
Outcome measures
| Measure |
Single Modality De-escalation Arm (SDA)
n=28 Participants
Radiotherapy alone or transoral robotic surgery
|
Intermediate De-escalation Arm (IDA)
n=34 Participants
TFHX (paclitaxel (100mg/m2 on day 1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle) or Cisplatin
|
Regular Dose Arm (RDA)
n=10 Participants
Regular dose chemoradiotherapy and TFHX (paclitaxel (100mg/m2 on day
1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle) or Cisplatin
|
|---|---|---|---|
|
Evaluate the Tumor Shrinkage (%) to Measure the Deep Response Rate (DRR)
|
25 Participants
|
26 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Counts below represent the number of patients in each treatment group with any adverse event. More detailed information is provided in the adverse events section.
All recorded adverse events will be listed and tabulated by system organ class, preferred term and treatment. Vital signs and clinical laboratory test results will be listed and summarized by treatment. Any significant physical examination findings, and clinical laboratory results will be listed. ECG readings will be evaluated by the investigator and abnormalities, if present, will be listed.
Outcome measures
| Measure |
Single Modality De-escalation Arm (SDA)
n=28 Participants
Radiotherapy alone or transoral robotic surgery
|
Intermediate De-escalation Arm (IDA)
n=34 Participants
TFHX (paclitaxel (100mg/m2 on day 1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle) or Cisplatin
|
Regular Dose Arm (RDA)
n=10 Participants
Regular dose chemoradiotherapy and TFHX (paclitaxel (100mg/m2 on day
1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle) or Cisplatin
|
|---|---|---|---|
|
Number of Patients With Adverse Events
|
27 Participants
|
29 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 24 monthsThe percent of patients who are alive and did not progress after two years.
Outcome measures
| Measure |
Single Modality De-escalation Arm (SDA)
n=28 Participants
Radiotherapy alone or transoral robotic surgery
|
Intermediate De-escalation Arm (IDA)
n=34 Participants
TFHX (paclitaxel (100mg/m2 on day 1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle) or Cisplatin
|
Regular Dose Arm (RDA)
n=10 Participants
Regular dose chemoradiotherapy and TFHX (paclitaxel (100mg/m2 on day
1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle) or Cisplatin
|
|---|---|---|---|
|
2 Year Progression-free Survival (PFS)
|
99 percentage of patients
Interval 77.0 to 99.0
|
88 percentage of patients
Interval 71.0 to 95.0
|
100 percentage of patients
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: From start date of therapy to the date of documented death, assessed up to 24 monthsThe percent of patients that are alive after 2 years of follow up. Rates are estimated using Kaplan-Meier survival methods.
Outcome measures
| Measure |
Single Modality De-escalation Arm (SDA)
n=28 Participants
Radiotherapy alone or transoral robotic surgery
|
Intermediate De-escalation Arm (IDA)
n=34 Participants
TFHX (paclitaxel (100mg/m2 on day 1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle) or Cisplatin
|
Regular Dose Arm (RDA)
n=10 Participants
Regular dose chemoradiotherapy and TFHX (paclitaxel (100mg/m2 on day
1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle) or Cisplatin
|
|---|---|---|---|
|
2 Year Overall Survival (OS)
|
96 percentage of patients in each arm
Interval 77.0 to 99.0
|
91 percentage of patients in each arm
Interval 74.0 to 97.0
|
87 percentage of patients in each arm
Interval 39.0 to 98.0
|
SECONDARY outcome
Timeframe: 24 monthsTime to locoregional failure rates will be estimated by the Kaplan-Meier methodology and comparisons will be made using the log-rank test.
Outcome measures
| Measure |
Single Modality De-escalation Arm (SDA)
n=28 Participants
Radiotherapy alone or transoral robotic surgery
|
Intermediate De-escalation Arm (IDA)
n=34 Participants
TFHX (paclitaxel (100mg/m2 on day 1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle) or Cisplatin
|
Regular Dose Arm (RDA)
n=10 Participants
Regular dose chemoradiotherapy and TFHX (paclitaxel (100mg/m2 on day
1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle) or Cisplatin
|
|---|---|---|---|
|
2 Year Rates of Locoregional Control
|
96 percentage of patients
Interval 77.0 to 99.0
|
96 percentage of patients
Interval 79.0 to 99.0
|
100 percentage of patients
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 24 monthsTime to distant failure rates will be estimated by the Kaplan-Meier methodology and comparisons will be made using the log-rank test.
Outcome measures
| Measure |
Single Modality De-escalation Arm (SDA)
n=28 Participants
Radiotherapy alone or transoral robotic surgery
|
Intermediate De-escalation Arm (IDA)
n=34 Participants
TFHX (paclitaxel (100mg/m2 on day 1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle) or Cisplatin
|
Regular Dose Arm (RDA)
n=10 Participants
Regular dose chemoradiotherapy and TFHX (paclitaxel (100mg/m2 on day
1), 5-fluorouracil continuous infusion (600mg/m2/d on days 0-5), and hydroxyurea (500mg orally twice daily on days 0-5 with 11 doses per cycle) or Cisplatin
|
|---|---|---|---|
|
2 Year Rates of Distant Control
|
100 percent of participants
Interval 100.0 to 100.0
|
97 percent of participants
Interval 80.0 to 99.0
|
100 percent of participants
Interval 100.0 to 100.0
|
Adverse Events
Single Modality De-escalation Arm (SDA)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 1 deaths
Intermediate De-escalation Arm (IDA)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 3 deaths
Regular Dose Arm (RDA)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Modality De-escalation Arm (SDA)
n=28 participants at risk
Patients with low risk, who do not qualify for TORS (due to volume of disease or poor visualization/access) or refuse TORS, who have ≥50% reduction by RECIST following induction chemotherapy will be given de-intensified treatment with radiation alone to 50 G.
Nivolumab: All enrolled patients will receive three 21-day cycles of nivolumab (360 mg on days 1; 3 doses total).
Adjuvant nivolumab will be offered to all patients for 6-months post completion of locoregional therapy for a total of 7 doses.
Transoral robotic surgery (TORS): Patients with low risk and small volume tonsillar disease (T1-T2, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) or base of tongue disease (T1-2 with lateralized primary ≤3 cm, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) who have ≥50% reduction by RECIST following induction chemotherapy will undergo TORS and selective nodal dissection. Patients may refuse TORS treatment. Patients will receive RT or TORS.
Adjuvant RT: Patients with low risk, who do not qualify for TORS (due to volume of disease or poor visualization/access) or refuse TORS, who have ≥50% reduction by RECIST following induction chemotherapy will be given de-intensified treatment with radiation alone to 50 Gy. Patients will receive RT or TORS.
|
Intermediate De-escalation Arm (IDA)
n=34 participants at risk
Patients who have high risk disease and ≥50% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 50 Gy with concurrent bolus cisplatin (x2 doses) or TFHX to 45 Gy (3 cycles).
|
Regular Dose Arm (RDA)
n=10 participants at risk
Following the induction treatments (carboplatin, nab-paclitaxel, and nivolumab), patients will be assessed based on response to chemotherapy and high or low risk status.
Patients who have low risk disease and \<30% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX (paclitaxel, 5-FU, hydroxyurea, dexamethasone, famotidine, and diphenhydramine) to 75 Gy (5 cycles).
Patients who have high risk disease and \<50% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX to 75 Gy (5 cycles).
Any patient who has progressive disease will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX to 75 Gy (5 cycles).
|
|---|---|---|---|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders
|
39.3%
11/28 • Number of events 11 • 5 years
|
38.2%
13/34 • Number of events 17 • 5 years
|
10.0%
1/10 • Number of events 3 • 5 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders- other
|
17.9%
5/28 • Number of events 7 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropena
|
0.00%
0/28 • 5 years
|
8.8%
3/34 • Number of events 5 • 5 years
|
0.00%
0/10 • 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.6%
1/28 • Number of events 1 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Atrial Afribilation
|
3.6%
1/28 • Number of events 1 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Chest pain- cardiac
|
3.6%
1/28 • Number of events 2 • 5 years
|
2.9%
1/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Myocardial infarction
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Sinus bradycardia
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
10.7%
3/28 • Number of events 3 • 5 years
|
8.8%
3/34 • Number of events 4 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Cardiac disorders other
|
10.7%
3/28 • Number of events 3 • 5 years
|
8.8%
3/34 • Number of events 4 • 5 years
|
0.00%
0/10 • 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
28.6%
8/28 • Number of events 9 • 5 years
|
17.6%
6/34 • Number of events 6 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Ear and labyrinth disorders
Hearing impared
|
14.3%
4/28 • Number of events 4 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
17.9%
5/28 • Number of events 5 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
30.0%
3/10 • Number of events 4 • 5 years
|
|
Endocrine disorders
Adrenal insufficiency
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Endocrine disorders
Hyperthyroidism
|
7.1%
2/28 • Number of events 2 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Endocrine disorders
Hypothyroidism
|
10.7%
3/28 • Number of events 3 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Eye disorders
Blurred vision
|
3.6%
1/28 • Number of events 1 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Eye disorders
Dry eye
|
0.00%
0/28 • 5 years
|
0.00%
0/34 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Eye disorders
Watering eyes
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Eye disorders
Eye disorders other
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/28 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
1/28 • Number of events 1 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Cheilitis
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
64.3%
18/28 • Number of events 23 • 5 years
|
55.9%
19/34 • Number of events 22 • 5 years
|
80.0%
8/10 • Number of events 9 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
32.1%
9/28 • Number of events 10 • 5 years
|
41.2%
14/34 • Number of events 21 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
42.9%
12/28 • Number of events 13 • 5 years
|
17.6%
6/34 • Number of events 6 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
2/28 • Number of events 2 • 5 years
|
8.8%
3/34 • Number of events 3 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
35.7%
10/28 • Number of events 15 • 5 years
|
52.9%
18/34 • Number of events 21 • 5 years
|
40.0%
4/10 • Number of events 4 • 5 years
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Flatulence
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
4/28 • Number of events 4 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.7%
3/28 • Number of events 3 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
46.4%
13/28 • Number of events 36 • 5 years
|
55.9%
19/34 • Number of events 64 • 5 years
|
50.0%
5/10 • Number of events 18 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
82.1%
23/28 • Number of events 37 • 5 years
|
61.8%
21/34 • Number of events 34 • 5 years
|
60.0%
6/10 • Number of events 9 • 5 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Oral pain
|
25.0%
7/28 • Number of events 11 • 5 years
|
41.2%
14/34 • Number of events 23 • 5 years
|
60.0%
6/10 • Number of events 8 • 5 years
|
|
Gastrointestinal disorders
Rectal Pain
|
7.1%
2/28 • Number of events 2 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
14.3%
4/28 • Number of events 7 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Toothache
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
32.1%
9/28 • Number of events 13 • 5 years
|
17.6%
6/34 • Number of events 7 • 5 years
|
40.0%
4/10 • Number of events 5 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
32.1%
9/28 • Number of events 15 • 5 years
|
8.8%
3/34 • Number of events 3 • 5 years
|
20.0%
2/10 • Number of events 3 • 5 years
|
|
General disorders
Chills
|
10.7%
3/28 • Number of events 3 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
General disorders
Edema face
|
7.1%
2/28 • Number of events 2 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
10.0%
1/10 • Number of events 2 • 5 years
|
|
General disorders
Edema limbs
|
10.7%
3/28 • Number of events 3 • 5 years
|
8.8%
3/34 • Number of events 4 • 5 years
|
20.0%
2/10 • Number of events 2 • 5 years
|
|
General disorders
Facial pain
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
General disorders
Fatigue
|
85.7%
24/28 • Number of events 51 • 5 years
|
73.5%
25/34 • Number of events 51 • 5 years
|
80.0%
8/10 • Number of events 15 • 5 years
|
|
General disorders
Fever
|
25.0%
7/28 • Number of events 7 • 5 years
|
8.8%
3/34 • Number of events 5 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/28 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
General disorders
Gait disturbance
|
7.1%
2/28 • Number of events 2 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
General disorders
Infusion related reaction
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
General disorders
Localized edema
|
10.7%
3/28 • Number of events 3 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
General disorders
Malaise
|
7.1%
2/28 • Number of events 2 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
General disorders
Neck edema
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
General disorders
Pain
|
14.3%
4/28 • Number of events 5 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
40.0%
4/10 • Number of events 7 • 5 years
|
|
General disorders
General disorders and administration site conditions - Other
|
10.7%
3/28 • Number of events 3 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/28 • 5 years
|
0.00%
0/34 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/28 • 5 years
|
0.00%
0/34 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Immune system disorders
Immune system disorders - Other
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Laryngitis
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Infections and infestations
Otitis media
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/28 • 5 years
|
8.8%
3/34 • Number of events 3 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/28 • 5 years
|
0.00%
0/34 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Infections and infestations
Skin infection
|
7.1%
2/28 • Number of events 3 • 5 years
|
0.00%
0/34 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Infections and infestations
Small intestine infection
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Upper respiratory infection
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/28 • 5 years
|
0.00%
0/34 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Infections and infestations
Infections and infestations - Other
|
7.1%
2/28 • Number of events 2 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
39.3%
11/28 • Number of events 13 • 5 years
|
50.0%
17/34 • Number of events 35 • 5 years
|
50.0%
5/10 • Number of events 11 • 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/28 • 5 years
|
8.8%
3/34 • Number of events 5 • 5 years
|
0.00%
0/10 • 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/28 • 5 years
|
0.00%
0/34 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other,
|
3.6%
1/28 • Number of events 1 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
35.7%
10/28 • Number of events 15 • 5 years
|
11.8%
4/34 • Number of events 8 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
7/28 • Number of events 7 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
21.4%
6/28 • Number of events 9 • 5 years
|
2.9%
1/34 • Number of events 2 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/28 • 5 years
|
5.9%
2/34 • Number of events 3 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Cholesterol high
|
3.6%
1/28 • Number of events 1 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Creatinine increased
|
10.7%
3/28 • Number of events 4 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Neutrophil count decreased
|
17.9%
5/28 • Number of events 5 • 5 years
|
11.8%
4/34 • Number of events 5 • 5 years
|
20.0%
2/10 • Number of events 2 • 5 years
|
|
Investigations
Platelet count decreased
|
3.6%
1/28 • Number of events 1 • 5 years
|
14.7%
5/34 • Number of events 5 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Investigations
Weight gain
|
3.6%
1/28 • Number of events 1 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Weight loss
|
14.3%
4/28 • Number of events 8 • 5 years
|
8.8%
3/34 • Number of events 6 • 5 years
|
20.0%
2/10 • Number of events 2 • 5 years
|
|
Investigations
White blood cell decreased
|
35.7%
10/28 • Number of events 12 • 5 years
|
20.6%
7/34 • Number of events 8 • 5 years
|
40.0%
4/10 • Number of events 4 • 5 years
|
|
Investigations
Investigations - Other
|
0.00%
0/28 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
20.0%
2/10 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
39.3%
11/28 • Number of events 13 • 5 years
|
38.2%
13/34 • Number of events 23 • 5 years
|
50.0%
5/10 • Number of events 6 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
1/28 • Number of events 1 • 5 years
|
11.8%
4/34 • Number of events 4 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
2/28 • Number of events 4 • 5 years
|
11.8%
4/34 • Number of events 5 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.6%
1/28 • Number of events 1 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
2/28 • Number of events 2 • 5 years
|
11.8%
4/34 • Number of events 4 • 5 years
|
20.0%
2/10 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/28 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Obesity
|
3.6%
1/28 • Number of events 2 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
4/28 • Number of events 5 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
20.0%
2/10 • Number of events 3 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.6%
1/28 • Number of events 1 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/28 • 5 years
|
8.8%
3/34 • Number of events 3 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
21.4%
6/28 • Number of events 6 • 5 years
|
11.8%
4/34 • Number of events 4 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
2/28 • Number of events 2 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
4/28 • Number of events 4 • 5 years
|
17.6%
6/34 • Number of events 6 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
17.9%
5/28 • Number of events 5 • 5 years
|
14.7%
5/34 • Number of events 5 • 5 years
|
20.0%
2/10 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
7.1%
2/28 • Number of events 2 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
17.9%
5/28 • Number of events 5 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Nervous system disorders
Dizziness
|
25.0%
7/28 • Number of events 8 • 5 years
|
14.7%
5/34 • Number of events 8 • 5 years
|
30.0%
3/10 • Number of events 6 • 5 years
|
|
Nervous system disorders
Dysarthia
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Nervous system disorders
Dysgeusia
|
60.7%
17/28 • Number of events 28 • 5 years
|
38.2%
13/34 • Number of events 14 • 5 years
|
20.0%
2/10 • Number of events 3 • 5 years
|
|
Nervous system disorders
Headache
|
25.0%
7/28 • Number of events 8 • 5 years
|
17.6%
6/34 • Number of events 6 • 5 years
|
20.0%
2/10 • Number of events 4 • 5 years
|
|
Nervous system disorders
Paresthesia
|
3.6%
1/28 • Number of events 2 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
17.9%
5/28 • Number of events 13 • 5 years
|
17.6%
6/34 • Number of events 11 • 5 years
|
0.00%
0/10 • 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
21.4%
6/28 • Number of events 10 • 5 years
|
29.4%
10/34 • Number of events 13 • 5 years
|
60.0%
6/10 • Number of events 10 • 5 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
10.0%
1/10 • Number of events 2 • 5 years
|
|
Nervous system disorders
Syncope
|
7.1%
2/28 • Number of events 2 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/28 • 5 years
|
0.00%
0/34 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Nervous system disorders
Nervous system disorders - Other
|
7.1%
2/28 • Number of events 3 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Eye disorders
Anxiety
|
7.1%
2/28 • Number of events 2 • 5 years
|
8.8%
3/34 • Number of events 4 • 5 years
|
10.0%
1/10 • Number of events 2 • 5 years
|
|
Psychiatric disorders
Confusion
|
3.6%
1/28 • Number of events 3 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Psychiatric disorders
Delirium
|
3.6%
1/28 • Number of events 1 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 2 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Insomnia
|
25.0%
7/28 • Number of events 8 • 5 years
|
20.6%
7/34 • Number of events 8 • 5 years
|
20.0%
2/10 • Number of events 3 • 5 years
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
10.0%
1/10 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
1/28 • Number of events 4 • 5 years
|
8.8%
3/34 • Number of events 3 • 5 years
|
20.0%
2/10 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Renal and urinary disorders
Urinary retention
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Renal and urinary disorders
Urine discoloration
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
3.6%
1/28 • Number of events 1 • 5 years
|
8.8%
3/34 • Number of events 4 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/28 • 5 years
|
0.00%
0/34 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.6%
1/28 • Number of events 1 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.6%
1/28 • Number of events 1 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
8/28 • Number of events 9 • 5 years
|
17.6%
6/34 • Number of events 10 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
4/28 • Number of events 4 • 5 years
|
8.8%
3/34 • Number of events 5 • 5 years
|
20.0%
2/10 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.6%
1/28 • Number of events 1 • 5 years
|
14.7%
5/34 • Number of events 5 • 5 years
|
20.0%
2/10 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.1%
2/28 • Number of events 2 • 5 years
|
8.8%
3/34 • Number of events 3 • 5 years
|
20.0%
2/10 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
1/28 • Number of events 1 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
3.6%
1/28 • Number of events 2 • 5 years
|
8.8%
3/34 • Number of events 5 • 5 years
|
20.0%
2/10 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
4/28 • Number of events 5 • 5 years
|
11.8%
4/34 • Number of events 5 • 5 years
|
20.0%
2/10 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
4/28 • Number of events 4 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
30.0%
3/10 • Number of events 5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/28 • 5 years
|
0.00%
0/34 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
21.4%
6/28 • Number of events 8 • 5 years
|
23.5%
8/34 • Number of events 9 • 5 years
|
40.0%
4/10 • Number of events 4 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/28 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.6%
1/28 • Number of events 1 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
21.4%
6/28 • Number of events 7 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.9%
5/28 • Number of events 7 • 5 years
|
14.7%
5/34 • Number of events 7 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
2/28 • Number of events 2 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/28 • 5 years
|
2.9%
1/34 • Number of events 2 • 5 years
|
10.0%
1/10 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
0.00%
0/10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/28 • 5 years
|
5.9%
2/34 • Number of events 5 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.4%
6/28 • Number of events 6 • 5 years
|
8.8%
3/34 • Number of events 5 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/28 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.6%
1/28 • Number of events 1 • 5 years
|
5.9%
2/34 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
28.6%
8/28 • Number of events 9 • 5 years
|
11.8%
4/34 • Number of events 5 • 5 years
|
0.00%
0/10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.6%
1/28 • Number of events 1 • 5 years
|
2.9%
1/34 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
25.0%
7/28 • Number of events 11 • 5 years
|
11.8%
4/34 • Number of events 6 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypertension
|
17.9%
5/28 • Number of events 12 • 5 years
|
14.7%
5/34 • Number of events 5 • 5 years
|
0.00%
0/10 • 5 years
|
|
Vascular disorders
Hypotension
|
7.1%
2/28 • Number of events 2 • 5 years
|
14.7%
5/34 • Number of events 5 • 5 years
|
20.0%
2/10 • Number of events 3 • 5 years
|
|
Skin and subcutaneous tissue disorders
Lymphedema
|
3.6%
1/28 • Number of events 1 • 5 years
|
0.00%
0/34 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place