Trial Outcomes & Findings for Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer (NCT NCT03067610)
NCT ID: NCT03067610
Last Updated: 2022-03-17
Results Overview
The crude risk of 2-year solitary elective volume recurrence will be calculated among all patients who are followed for at least 2 years. Patients who die before 2 years without an SEVR will be included in the denominator.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
2 years
Results posted on
2022-03-17
Participant Flow
Participant milestones
| Measure |
Radiation Therapy
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). There was only one study arm. The radiation field and dose are the same with or without chemotherapy. The intent is to assess the effects of radiation therapy, regardless of chemotherapy treatment.
Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
|
|---|---|
|
Overall Study
STARTED
|
72
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Radiation Therapy
n=72 Participants
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
|
|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
58 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=99 Participants
|
|
Disease site
Oropharynx
|
51 Participants
n=99 Participants
|
|
Disease site
Larynx
|
21 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe crude risk of 2-year solitary elective volume recurrence will be calculated among all patients who are followed for at least 2 years. Patients who die before 2 years without an SEVR will be included in the denominator.
Outcome measures
| Measure |
Radiation Therapy
n=72 Participants
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
|
Total Cohort 3 Month
Total cohort
|
Total Cohort 6 Month
Total cohort
|
Total Cohort 12 Month
Total cohort
|
|---|---|---|---|---|
|
Number of Patients With Solitary Elective Volume Recurrence
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsQuality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI). EORTC QLQ-C30 and QLQ-H\&N35 are scored on a 4-point categorical scale ranging from 1 "not at all" to 4 "very much". This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms. MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning.
Outcome measures
| Measure |
Radiation Therapy
n=72 Participants
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
|
Total Cohort 3 Month
n=57 Participants
Total cohort
|
Total Cohort 6 Month
n=44 Participants
Total cohort
|
Total Cohort 12 Month
n=43 Participants
Total cohort
|
|---|---|---|---|---|
|
Quality of Life (QOL) Patient Reported Outcomes (PRO)
EORTC QLQ30 global
|
71.4 score on a scale
Standard Error 2.3
|
76.9 score on a scale
Standard Error 2.6
|
79.2 score on a scale
Standard Error 2.8
|
85.9 score on a scale
Standard Error 2.3
|
|
Quality of Life (QOL) Patient Reported Outcomes (PRO)
EORTC QLQ30 physical fcn
|
90.3 score on a scale
Standard Error 1.7
|
87.4 score on a scale
Standard Error 2.3
|
90.3 score on a scale
Standard Error 2.4
|
93.0 score on a scale
Standard Error 1.8
|
|
Quality of Life (QOL) Patient Reported Outcomes (PRO)
EORTC QLQ30 role fcn
|
81.9 score on a scale
Standard Error 3.0
|
82.5 score on a scale
Standard Error 3.4
|
85.6 score on a scale
Standard Error 3.6
|
95.3 score on a scale
Standard Error 2.2
|
|
Quality of Life (QOL) Patient Reported Outcomes (PRO)
EORTC QLQ30 emotional fcn
|
78.0 score on a scale
Standard Error 2.8
|
87.7 score on a scale
Standard Error 2.7
|
82.9 score on a scale
Standard Error 3.7
|
88.2 score on a scale
Standard Error 3.2
|
|
Quality of Life (QOL) Patient Reported Outcomes (PRO)
EORTC QLQ30 cognitive fcn
|
90.0 score on a scale
Standard Error 1.9
|
89.5 score on a scale
Standard Error 2.7
|
86.4 score on a scale
Standard Error 3.1
|
90.7 score on a scale
Standard Error 2.9
|
|
Quality of Life (QOL) Patient Reported Outcomes (PRO)
EORTC QLQ30 social fcn
|
85.2 score on a scale
Standard Error 2.4
|
85.1 score on a scale
Standard Error 3.5
|
85.6 score on a scale
Standard Error 3.7
|
90.3 score on a scale
Standard Error 3.4
|
|
Quality of Life (QOL) Patient Reported Outcomes (PRO)
EORTC HN35 dry mouth
|
14.4 score on a scale
Standard Error 2.8
|
59.0 score on a scale
Standard Error 4.1
|
47.7 score on a scale
Standard Error 4.5
|
38.0 score on a scale
Standard Error 4.2
|
|
Quality of Life (QOL) Patient Reported Outcomes (PRO)
EORTC HN35 sticky saliva
|
15.7 score on a scale
Standard Error 3.2
|
38.0 score on a scale
Standard Error 4.4
|
27.3 score on a scale
Standard Error 4.4
|
27.1 score on a scale
Standard Error 4.6
|
|
Quality of Life (QOL) Patient Reported Outcomes (PRO)
EORTC HN35 senses
|
6.7 score on a scale
Standard Error 1.8
|
25.7 score on a scale
Standard Error 2.9
|
20.1 score on a scale
Standard Error 3.3
|
15.9 score on a scale
Standard Error 2.7
|
|
Quality of Life (QOL) Patient Reported Outcomes (PRO)
EORTC HN35 pain
|
24.4 score on a scale
Standard Error 2.7
|
16.5 score on a scale
Standard Error 2.7
|
14.2 score on a scale
Standard Error 3.3
|
7.9 score on a scale
Standard Error 2.3
|
|
Quality of Life (QOL) Patient Reported Outcomes (PRO)
EORTC HN35 speech
|
18.4 score on a scale
Standard Error 2.9
|
13.4 score on a scale
Standard Error 2.6
|
19.2 score on a scale
Standard Error 4.5
|
9.8 score on a scale
Standard Error 2.6
|
|
Quality of Life (QOL) Patient Reported Outcomes (PRO)
Composite MDADI
|
81.3 score on a scale
Standard Error 1.9
|
79.6 score on a scale
Standard Error 2.0
|
76.9 score on a scale
Standard Error 2.6
|
84.9 score on a scale
Standard Error 2.3
|
SECONDARY outcome
Timeframe: 2 yearsOnly adverse events (grade 3-5) assessed to be definitely, probably, or possibly related to protocol treatment up to 2 years post-treatment will be considered. This was measured according to NCI's CTCAE v4.0 toxicity criteria.
Outcome measures
| Measure |
Radiation Therapy
n=33 Participants
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
|
Total Cohort 3 Month
Total cohort
|
Total Cohort 6 Month
Total cohort
|
Total Cohort 12 Month
Total cohort
|
|---|---|---|---|---|
|
Number of Participants With Definite, Possible, and Probable Protocol-related Toxicities (Grade 3-5)
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearsThe prevalence of gastrostomy use up to 2 years will be described.
Outcome measures
| Measure |
Radiation Therapy
n=72 Participants
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
|
Total Cohort 3 Month
Total cohort
|
Total Cohort 6 Month
Total cohort
|
Total Cohort 12 Month
Total cohort
|
|---|---|---|---|---|
|
Total Number of Participants With Gastrostomy Dependence
|
31 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Collected data were not considered valid due to software limitations as it was not available to auto-calculate the data as proposed by our EMR
The average patient utilities (derived from EQ-5D) from baseline up to 2 years from the end of treatment will be described. Changes in patient utility will be analyzed using generalized estimated equations (GEE).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Reported the percentage of the total patient population who survived to 2 years post-treatment.
Overall survival will be calculated from the initiation of treatment using the Kaplan-Meier method.
Outcome measures
| Measure |
Radiation Therapy
n=72 Participants
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
|
Total Cohort 3 Month
Total cohort
|
Total Cohort 6 Month
Total cohort
|
Total Cohort 12 Month
Total cohort
|
|---|---|---|---|---|
|
Overall Survival
|
89 percentage of patients
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearPopulation: Percentage of the total patient population with progression-free survival 2 years post treatment
Progression-free survival will be calculated from the initiation of treatment. Progression is confirmed by biopsy, which will be used as the date of progression.
Outcome measures
| Measure |
Radiation Therapy
n=72 Participants
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
|
Total Cohort 3 Month
Total cohort
|
Total Cohort 6 Month
Total cohort
|
Total Cohort 12 Month
Total cohort
|
|---|---|---|---|---|
|
Progression-free Survival
|
79 percentage of patients
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearsThe percentage of patients with locoregional or distant failure within 2 years of treatment will be estimated using cumulative incidence statistics, with death serving as the competing risk. Cumulative incidence refers to the estimated risk/probability of tumor failure within 2 years of treatment, either locoregional recurrence or distant metastasis, accounting for the competing risk of death.
Outcome measures
| Measure |
Radiation Therapy
n=72 Participants
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
|
Total Cohort 3 Month
Total cohort
|
Total Cohort 6 Month
Total cohort
|
Total Cohort 12 Month
Total cohort
|
|---|---|---|---|---|
|
Probability of Locoregional or Distant Tumor Failure
Locoregional recurrence
|
14 percentage of patients
|
—
|
—
|
—
|
|
Probability of Locoregional or Distant Tumor Failure
Distant metastasis
|
14 percentage of patients
|
—
|
—
|
—
|
Adverse Events
Radiation Therapy
Serious events: 35 serious events
Other events: 65 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Radiation Therapy
n=72 participants at risk
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Nervous system disorders
Acute Encephalopathy
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.8%
2/72 • Number of events 3 • 30 months
|
|
Vascular disorders
acute mescenteric ischemia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Immune system disorders
Allergic Reaction
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Blood and lymphatic system disorders
anemia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Anorexia
|
9.7%
7/72 • Number of events 7 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
General disorders
Atypical Chest Pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
chills
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
8/72 • Number of events 8 • 30 months
|
|
Psychiatric disorders
Delirium
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Psychiatric disorders
depression
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Nervous system disorders
dizziness
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
dysphagia
|
19.4%
14/72 • Number of events 14 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
4/72 • Number of events 4 • 30 months
|
|
General disorders
fatigue
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
General disorders
fever
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Fracture
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnic Respiratory Failure
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
hypernatremia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Vascular disorders
Hypertension
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
hyponatremia
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Vascular disorders
hypotensive
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Infections and infestations
Lung infection
|
4.2%
3/72 • Number of events 3 • 30 months
|
|
Gastrointestinal disorders
nausea
|
5.6%
4/72 • Number of events 4 • 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm of unknown etiology
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Neutropenic Fever
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Opioid Overdose
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Gastrointestinal disorders
Oral Mucositis
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Nervous system disorders
parethesia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Radiation Dermatitis
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Nervous system disorders
seizure
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Infections and infestations
sepsis
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
General disorders
Severe systemic inflammatory response syndrome
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Infections and infestations
Skin infection (cellulitis )
|
1.4%
1/72 • Number of events 1 • 30 months
|
Other adverse events
| Measure |
Radiation Therapy
n=72 participants at risk
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
1/72 • 30 months
|
|
Gastrointestinal disorders
abdominal pain
|
25.0%
18/72 • 30 months
|
|
General disorders
abscess of chin
|
1.4%
1/72 • 30 months
|
|
Gastrointestinal disorders
Acid Reflex
|
15.3%
11/72 • 30 months
|
|
Skin and subcutaneous tissue disorders
acne vulgaris
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Acneform rash
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Psychiatric disorders
agitated
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Albumin Decreased
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Investigations
alkaline phosphate decreased
|
4.2%
3/72 • Number of events 3 • 30 months
|
|
Investigations
alkaline phosphatase increased
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Immune system disorders
Allergic Reaction
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.3%
6/72 • Number of events 6 • 30 months
|
|
Skin and subcutaneous tissue disorders
alopecia
|
1.4%
1/72 • 30 months
|
|
Investigations
ALP increased
|
2.8%
2/72 • 30 months
|
|
Investigations
ALT decreased
|
4.2%
3/72 • 30 months
|
|
Investigations
ALT increased
|
15.3%
11/72 • 30 months
|
|
General disorders
altered mental status
|
5.6%
4/72 • 30 months
|
|
Nervous system disorders
altered sensation
|
2.8%
2/72 • 30 months
|
|
Infections and infestations
Anaerobic infection
|
1.4%
1/72 • 30 months
|
|
Blood and lymphatic system disorders
anemia
|
62.5%
45/72 • Number of events 115 • 30 months
|
|
Metabolism and nutrition disorders
Anorexia
|
34.7%
25/72 • Number of events 30 • 30 months
|
|
Psychiatric disorders
anxiety
|
27.8%
20/72 • Number of events 23 • 30 months
|
|
Injury, poisoning and procedural complications
Aortic injury
|
1.4%
1/72 • 30 months
|
|
Nervous system disorders
aphonia
|
1.4%
1/72 • 30 months
|
|
Gastrointestinal disorders
appetite change
|
2.8%
2/72 • 30 months
|
|
General disorders
Arm pain
|
1.4%
1/72 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
2/72 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.8%
2/72 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
9.7%
7/72 • Number of events 8 • 30 months
|
|
Investigations
AST increased
|
9.7%
7/72 • Number of events 9 • 30 months
|
|
General disorders
asthenia
|
1.4%
1/72 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
1.4%
1/72 • 30 months
|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
1/72 • 30 months
|
|
General disorders
Atypical Chest Pain
|
2.8%
2/72 • 30 months
|
|
Vascular disorders
AV block 1st Degree
|
1.4%
1/72 • 30 months
|
|
Investigations
Azotemia
|
1.4%
1/72 • 30 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
20.8%
15/72 • 30 months
|
|
General disorders
BCC Nose
|
1.4%
1/72 • 30 months
|
|
General disorders
bite wound
|
1.4%
1/72 • 30 months
|
|
Renal and urinary disorders
bladder incontinence
|
1.4%
1/72 • 30 months
|
|
General disorders
bleeding from mouth
|
1.4%
1/72 • 30 months
|
|
Eye disorders
blurred vision
|
15.3%
11/72 • 30 months
|
|
Gastrointestinal disorders
Bloating
|
4.2%
3/72 • 30 months
|
|
Vascular disorders
bloody secretion
|
2.8%
2/72 • 30 months
|
|
Gastrointestinal disorders
bowel incontinence
|
1.4%
1/72 • 30 months
|
|
Cardiac disorders
Bradycardia
|
1.4%
1/72 • 30 months
|
|
Hepatobiliary disorders
breast pain
|
1.4%
1/72 • 30 months
|
|
General disorders
breast swelling
|
1.4%
1/72 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.4%
1/72 • 30 months
|
|
Cardiac disorders
Coronary Artery Disease
|
2.8%
2/72 • 30 months
|
|
Investigations
calcium count increased
|
1.4%
1/72 • 30 months
|
|
Investigations
Cardiac troponin I increased
|
1.4%
1/72 • 30 months
|
|
Infections and infestations
Cellulitis
|
2.8%
2/72 • 30 months
|
|
Musculoskeletal and connective tissue disorders
cervical stenosis of spine
|
1.4%
1/72 • 30 months
|
|
Musculoskeletal and connective tissue disorders
cervicalgia
|
1.4%
1/72 • 30 months
|
|
Skin and subcutaneous tissue disorders
change in mole
|
2.8%
2/72 • 30 months
|
|
Gastrointestinal disorders
Cheilitis
|
1.4%
1/72 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
1.4%
1/72 • 30 months
|
|
General disorders
chest pain
|
8.3%
6/72 • 30 months
|
|
General disorders
chest tightness
|
1.4%
1/72 • 30 months
|
|
Cardiac disorders
chest wall pain
|
1.4%
1/72 • 30 months
|
|
General disorders
chills
|
6.9%
5/72 • 30 months
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
4.2%
3/72 • 30 months
|
|
General disorders
Cold Intolerance
|
11.1%
8/72 • 30 months
|
|
Psychiatric disorders
confusion
|
5.6%
4/72 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
congestion
|
5.6%
4/72 • 30 months
|
|
Gastrointestinal disorders
constipation
|
76.4%
55/72 • 30 months
|
|
Skin and subcutaneous tissue disorders
contact dermatitis
|
1.4%
1/72 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
33.3%
24/72 • 30 months
|
|
Investigations
creatinine decreased
|
9.7%
7/72 • 30 months
|
|
Investigations
creatinine increased
|
20.8%
15/72 • 30 months
|
|
Renal and urinary disorders
cystitis
|
1.4%
1/72 • 30 months
|
|
Metabolism and nutrition disorders
decreased appetite
|
4.2%
3/72 • 30 months
|
|
Investigations
Decreased platelet count
|
2.8%
2/72 • 30 months
|
|
Renal and urinary disorders
decreased urine output
|
1.4%
1/72 • 30 months
|
|
Investigations
decreased WBC
|
2.8%
2/72 • 30 months
|
|
Metabolism and nutrition disorders
Dehydration
|
37.5%
27/72 • 30 months
|
|
Infections and infestations
dental infection
|
1.4%
1/72 • 30 months
|
|
Psychiatric disorders
depression
|
20.8%
15/72 • 30 months
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
1.4%
1/72 • 30 months
|
|
Metabolism and nutrition disorders
Diabetes
|
4.2%
3/72 • 30 months
|
|
Metabolism and nutrition disorders
diaphoresis
|
12.5%
9/72 • 30 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
24/72 • 30 months
|
|
Skin and subcutaneous tissue disorders
discoloration of tongue
|
1.4%
1/72 • 30 months
|
|
General disorders
Discolored discharge
|
1.4%
1/72 • 30 months
|
|
Nervous system disorders
dizziness
|
29.2%
21/72 • 30 months
|
|
Eye disorders
double vision
|
1.4%
1/72 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
dry cough
|
1.4%
1/72 • 30 months
|
|
Gastrointestinal disorders
dry mouth
|
83.3%
60/72 • 30 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
4.2%
3/72 • 30 months
|
|
Gastrointestinal disorders
Dsyphagia
|
1.4%
1/72 • 30 months
|
|
Vascular disorders
DVT
|
1.4%
1/72 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
dypsnea
|
2.8%
2/72 • 30 months
|
|
Nervous system disorders
Dysesthesia
|
1.4%
1/72 • 30 months
|
|
Nervous system disorders
dysgeusia
|
90.3%
65/72 • 30 months
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
5/72 • 30 months
|
|
Gastrointestinal disorders
Dysphagia
|
87.5%
63/72 • 30 months
|
|
General disorders
dysphonia
|
6.9%
5/72 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
5.6%
4/72 • 30 months
|
|
Renal and urinary disorders
dysuria
|
5.6%
4/72 • 30 months
|
|
Ear and labyrinth disorders
ear ache
|
1.4%
1/72 • 30 months
|
|
Ear and labyrinth disorders
ear congestion
|
2.8%
2/72 • 30 months
|
|
Ear and labyrinth disorders
Ear disorder - other
|
1.4%
1/72 • 30 months
|
|
Ear and labyrinth disorders
Ear infection
|
2.8%
2/72 • 30 months
|
|
Ear and labyrinth disorders
ear pain
|
23.6%
17/72 • 30 months
|
|
Vascular disorders
easy bruising
|
2.8%
2/72 • 30 months
|
|
General disorders
Edema
|
18.1%
13/72 • 30 months
|
|
General disorders
Edema limbs
|
1.4%
1/72 • 30 months
|
|
General disorders
elbow pain
|
1.4%
1/72 • 30 months
|
|
Investigations
elevated ANC
|
1.4%
1/72 • 30 months
|
|
Investigations
elevated bilirubin
|
2.8%
2/72 • 30 months
|
|
Investigations
elevated CO2
|
1.4%
1/72 • 30 months
|
|
Investigations
elevated creatinine
|
13.9%
10/72 • 30 months
|
|
Investigations
Elevated prothrombin
|
1.4%
1/72 • 30 months
|
|
Investigations
elevated WBC
|
1.4%
1/72 • 30 months
|
|
Hepatobiliary disorders
emesis
|
2.8%
2/72 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.8%
2/72 • 30 months
|
|
Skin and subcutaneous tissue disorders
erythema
|
29.2%
21/72 • 30 months
|
|
Gastrointestinal disorders
esophagitis
|
1.4%
1/72 • 30 months
|
|
Eye disorders
eye disorder- other
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Eye disorders
Eye pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Eye disorders
Eye redness
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Facial edema
|
1.4%
1/72 • Number of events 2 • 30 months
|
|
Skin and subcutaneous tissue disorders
Facial rash
|
5.6%
4/72 • Number of events 4 • 30 months
|
|
General disorders
Facial swelling
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Blood and lymphatic system disorders
Factor V
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Fall
|
15.3%
11/72 • Number of events 13 • 30 months
|
|
General disorders
Fatigue
|
80.6%
58/72 • Number of events 103 • 30 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Fever
|
16.7%
12/72 • Number of events 17 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Vascular disorders
Flushing
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Nervous system disorders
Focal weakness
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
General disorders
Foot pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Fracture
|
4.2%
3/72 • Number of events 3 • 30 months
|
|
Gastrointestinal disorders
G tube dysfunction
|
4.2%
3/72 • Number of events 3 • 30 months
|
|
Gastrointestinal disorders
G tube placement
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - other, melena
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Gastroparesis
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
General disorders
Generalized weakness
|
23.6%
17/72 • Number of events 22 • 30 months
|
|
Gastrointestinal disorders
GERD
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Gastrointestinal disorders
Gingival ulceration
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
11.1%
8/72 • Number of events 9 • 30 months
|
|
Psychiatric disorders
Hallucinations
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Nervous system disorders
Headache
|
25.0%
18/72 • Number of events 27 • 30 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Ear and labyrinth disorders
Hearing loss
|
18.1%
13/72 • Number of events 14 • 30 months
|
|
Gastrointestinal disorders
Heartburn
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
General disorders
Heat intolerance
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Hematochezia (rectal bleeding)
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Renal and urinary disorders
Hematuria
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
5.6%
4/72 • Number of events 4 • 30 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Hernia
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Investigations
High cholesterol
|
4.2%
3/72 • Number of events 3 • 30 months
|
|
General disorders
Hip pain
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
29.2%
21/72 • Number of events 25 • 30 months
|
|
Vascular disorders
Hot flashes
|
5.6%
4/72 • Number of events 5 • 30 months
|
|
Investigations
Hypochloride
|
31.9%
23/72 • Number of events 52 • 30 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.1%
8/72 • Number of events 10 • 30 months
|
|
Investigations
Hyperchloride
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.6%
22/72 • Number of events 43 • 30 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
12/72 • Number of events 18 • 30 months
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.2%
3/72 • Number of events 5 • 30 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
1.4%
1/72 • Number of events 2 • 30 months
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
9.7%
7/72 • Number of events 7 • 30 months
|
|
Gastrointestinal disorders
Hypersalivation
|
2.8%
2/72 • Number of events 3 • 30 months
|
|
Vascular disorders
Hypertension
|
58.3%
42/72 • Number of events 88 • 30 months
|
|
Endocrine disorders
Hyperthyroid
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.1%
13/72 • Number of events 27 • 30 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.9%
10/72 • Number of events 22 • 30 months
|
|
Investigations
Hypochloremia
|
4.2%
3/72 • Number of events 4 • 30 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.6%
4/72 • Number of events 4 • 30 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.6%
17/72 • Number of events 32 • 30 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.8%
15/72 • Number of events 24 • 30 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
36.1%
26/72 • Number of events 54 • 30 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.6%
4/72 • Number of events 4 • 30 months
|
|
Investigations
Hypophosphorous
|
2.8%
2/72 • Number of events 4 • 30 months
|
|
Vascular disorders
Hypotension
|
16.7%
12/72 • Number of events 13 • 30 months
|
|
Endocrine disorders
Hypothyroidism
|
6.9%
5/72 • Number of events 5 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Infections and infestations
Infection
|
9.7%
7/72 • Number of events 7 • 30 months
|
|
Infections and infestations
Infections and infestations - other, COVID-19
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Inflammation
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Infections and infestations
Influenza (flu-like symptoms)
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Injury, other, (mild fall injury)
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Psychiatric disorders
Insomnia
|
40.3%
29/72 • Number of events 32 • 30 months
|
|
General disorders
Itching
|
4.2%
3/72 • Number of events 3 • 30 months
|
|
General disorders
Jaw Pain
|
8.3%
6/72 • Number of events 7 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Jaw Spasm
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
15.3%
11/72 • Number of events 12 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Metabolism and nutrition disorders
L Elbow Pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
L knee pain
|
1.4%
1/72 • Number of events 2 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Edema
|
11.1%
8/72 • Number of events 10 • 30 months
|
|
Infections and infestations
Laryngitis
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
LE edema
|
5.6%
4/72 • Number of events 4 • 30 months
|
|
Investigations
Leukocytosis
|
6.9%
5/72 • Number of events 6 • 30 months
|
|
Investigations
Leukopenia
|
1.4%
1/72 • Number of events 2 • 30 months
|
|
General disorders
Leukoplakia
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
General disorders
Localized edema
|
31.9%
23/72 • Number of events 30 • 30 months
|
|
General disorders
Loss of smell
|
11.1%
8/72 • Number of events 9 • 30 months
|
|
General disorders
Low total protein
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Lower extremity pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Nervous system disorders
Lumbar stenosis
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Lump on abdomen
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Lung infection
|
6.9%
5/72 • Number of events 5 • 30 months
|
|
General disorders
Lymphadenopathy
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
General disorders
Lymphadema
|
41.7%
30/72 • Number of events 32 • 30 months
|
|
Investigations
Lymphocyte count decreased
|
70.8%
51/72 • Number of events 194 • 30 months
|
|
Skin and subcutaneous tissue disorders
Macular rash
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal fistula
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Nervous system disorders
Memory loss
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Psychiatric disorders
Mental confusion
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Ear and labyrinth disorders
Middle-ear infection
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Migraines
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Mild odynophagia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Mouth pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Mouth sores
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Infections and infestations
Mucosal infection
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Mucositis
|
36.1%
26/72 • Number of events 47 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder - other
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
15.3%
11/72 • Number of events 13 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
30.6%
22/72 • Number of events 25 • 30 months
|
|
Gastrointestinal disorders
Nausea
|
69.4%
50/72 • Number of events 97 • 30 months
|
|
General disorders
Neck edema
|
8.3%
6/72 • Number of events 8 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
54.2%
39/72 • Number of events 58 • 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign - other
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Nervous system disorders
Nervous system disorder - other
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Nervous system disorders
Neuropathy
|
4.2%
3/72 • Number of events 3 • 30 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Investigations
Neutrophil count decreased
|
22.2%
16/72 • Number of events 30 • 30 months
|
|
Investigations
Neutrophil count increased
|
9.7%
7/72 • Number of events 13 • 30 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.6%
4/72 • Number of events 4 • 30 months
|
|
Renal and urinary disorders
Nocturia
|
9.7%
7/72 • Number of events 7 • 30 months
|
|
General disorders
Nocturnal "sweats"
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Non-cardiac chest pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Nose bleeds
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Obesity
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Odynophagia
|
90.3%
65/72 • Number of events 148 • 30 months
|
|
Nervous system disorders
Oral dysesthesia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Oral lesions
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Oral mucositis
|
59.7%
43/72 • Number of events 88 • 30 months
|
|
Gastrointestinal disorders
Oral pain
|
77.8%
56/72 • Number of events 124 • 30 months
|
|
Infections and infestations
Oral thrush
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
General disorders
Oropharyngeal edema
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnea
|
6.9%
5/72 • Number of events 5 • 30 months
|
|
Ear and labyrinth disorders
Otalgia
|
1.4%
1/72 • Number of events 2 • 30 months
|
|
Ear and labyrinth disorders
Otic pain (L ear)
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Overdose
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Pain
|
9.7%
7/72 • Number of events 9 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Skin and subcutaneous tissue disorders
Pallor
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Cardiac disorders
Palpitations
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Infections and infestations
Papulopustular rash
|
1.4%
1/72 • Number of events 2 • 30 months
|
|
Nervous system disorders
Parathesia
|
6.9%
5/72 • Number of events 6 • 30 months
|
|
Nervous system disorders
Peripheral neuropathy
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Vascular disorders
Phlebitis
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Eye disorders
Photophobia
|
1.4%
1/72 • Number of events 2 • 30 months
|
|
Investigations
Platelet count decreased
|
43.1%
31/72 • Number of events 54 • 30 months
|
|
Investigations
Platelet count increased
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Polydipsia
|
8.3%
6/72 • Number of events 7 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
43.1%
31/72 • Number of events 42 • 30 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
3/72 • Number of events 3 • 30 months
|
|
Vascular disorders
Pulmonary embolism
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Ear and labyrinth disorders
R Otalgia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
88.9%
64/72 • Number of events 114 • 30 months
|
|
Injury, poisoning and procedural complications
Radiation ulceration
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.4%
14/72 • Number of events 19 • 30 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
rectal bleeding
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
rectal fissue
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Rectal pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Eye disorders
Red eyes
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Reflux
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Renal and urinary disorders
Bladder prolapse
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder- other
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchus
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Rib pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Right arm pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Right chin pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Ear and labyrinth disorders
Right ear pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Eye disorders
Right eye pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Right inguinal hernia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Right jaw pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Saliva pooling
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
5.6%
4/72 • Number of events 6 • 30 months
|
|
Gastrointestinal disorders
Salivary inflammation
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Seasonal allergies
|
11.1%
8/72 • Number of events 8 • 30 months
|
|
General disorders
Sensory change
|
8.3%
6/72 • Number of events 7 • 30 months
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
4.2%
3/72 • Number of events 3 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
12.5%
9/72 • Number of events 10 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pressure
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Cardiac disorders
Sinus tachycardia
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Infections and infestations
Sinusitis
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Skin disorder- other
|
4.2%
3/72 • Number of events 3 • 30 months
|
|
Skin and subcutaneous tissue disorders
Skin erythema
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.9%
5/72 • Number of events 6 • 30 months
|
|
Infections and infestations
Skin infection
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Skin and subcutaneous tissue disorders
Skin pigmentation
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
4.2%
3/72 • Number of events 3 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
15.3%
11/72 • Number of events 11 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
72.2%
52/72 • Number of events 127 • 30 months
|
|
General disorders
Speech change
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Infections and infestations
Stoma site infection
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
General disorders
Stomal pain
|
5.6%
4/72 • Number of events 6 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
2.8%
2/72 • Number of events 4 • 30 months
|
|
Surgical and medical procedures
Surgical Procedure - other
|
13.9%
10/72 • Number of events 10 • 30 months
|
|
Nervous system disorders
Syncope
|
4.2%
3/72 • Number of events 3 • 30 months
|
|
Nervous system disorders
Syncopal
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Cardiac disorders
Tachycardia
|
11.1%
8/72 • Number of events 10 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Gastrointestinal disorders
Thick saliva
|
9.7%
7/72 • Number of events 7 • 30 months
|
|
General disorders
Thick secretions
|
68.1%
49/72 • Number of events 83 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
16.7%
12/72 • Number of events 15 • 30 months
|
|
Infections and infestations
Thrush
|
51.4%
37/72 • Number of events 50 • 30 months
|
|
Ear and labyrinth disorders
Tinnitus
|
27.8%
20/72 • Number of events 28 • 30 months
|
|
Gastrointestinal disorders
Toothache
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Investigations
Total bilirubin elevated
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Investigations
Total protein decreased
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Infections and infestations
Tracheitis
|
1.4%
1/72 • Number of events 4 • 30 months
|
|
Nervous system disorders
Tremors
|
4.2%
3/72 • Number of events 3 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
9.7%
7/72 • Number of events 7 • 30 months
|
|
Investigations
TSH elevated
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Ulceration
|
6.9%
5/72 • Number of events 6 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
2.8%
2/72 • Number of events 2 • 30 months
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
12/72 • Number of events 12 • 30 months
|
|
Renal and urinary disorders
Urinary incontinence
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Renal and urinary disorders
Urinary retention
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Infections and infestations
Urinary tract infection
|
6.9%
5/72 • Number of events 6 • 30 months
|
|
Renal and urinary disorders
Urinary urgency
|
9.7%
7/72 • Number of events 7 • 30 months
|
|
Renal and urinary disorders
Urine output decreased
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Velopharyngeal insufficiency (VPI)
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
19.4%
14/72 • Number of events 15 • 30 months
|
|
Gastrointestinal disorders
Vomiting
|
36.1%
26/72 • Number of events 46 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
5.6%
4/72 • Number of events 4 • 30 months
|
|
Investigations
Weight gain
|
8.3%
6/72 • Number of events 6 • 30 months
|
|
Investigations
Weight loss
|
84.7%
61/72 • Number of events 119 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
11.1%
8/72 • Number of events 8 • 30 months
|
|
Investigations
White blood cell count increased
|
11.1%
8/72 • Number of events 12 • 30 months
|
|
Investigations
White blood cell count decreased
|
50.0%
36/72 • Number of events 93 • 30 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.4%
1/72 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Xerostomia
|
1.4%
1/72 • Number of events 1 • 30 months
|
Additional Information
Dr. David Sher
University of Texas Southwestern Medical Center
Phone: 214/645-7607
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place