Trial Outcomes & Findings for Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy (NCT NCT01682031)
NCT ID: NCT01682031
Last Updated: 2014-08-22
Results Overview
Will be compared as difference in proportions with 95% confidence intervals.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2014-08-22
Participant Flow
Participant milestones
| Measure |
Arm I (Placebo, Cisplatin, and Radiotherapy)
Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies
|
Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Arm I (Placebo, Cisplatin, and Radiotherapy)
Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies
|
Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
MRI results indicate increased nodul
|
0
|
1
|
|
Overall Study
Patient could not swallow tablets
|
1
|
0
|
|
Overall Study
Patient stopped selenium on his own
|
0
|
1
|
Baseline Characteristics
Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy
Baseline characteristics by cohort
| Measure |
Arm I (Placebo, Cisplatin, and Radiotherapy)
n=8 Participants
Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies
|
Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
n=10 Participants
Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Will be compared as difference in proportions with 95% confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post-treatmentPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Will be compared as difference in proportions with 95% confidence intervals. Disease will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 yearPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Assessed by Kaplan-Meier RFS curves and the proportion with an event at 1 year for RFS will be compared simultaneously to obtain more global sensitivity to differences in time-to-event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post-treatmentPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Estimated using the Kaplan-Meier method. Log-rank tests will be used for the comparison of survival distributions among study groups. Continuous endpoints will be summarized using means, standard deviations and percentiles.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 year post-treatmentPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post-treatmentPopulation: All treated and eligible patients
Will be compared as difference in proportions with 95% confidence intervals.
Outcome measures
| Measure |
Arm I (Placebo, Cisplatin, and Radiotherapy)
n=8 Participants
Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies
|
Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
n=10 Participants
Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia
|
1 number of xerostomia events
|
0 number of xerostomia events
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
This characteristic will be included in Cox models.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 months post-treatmentPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Descriptive statistics will be used to describe the mean plasma cisplatin and selenium at each time point. Repeated measures analysis of variance will be used to evaluate the changes in plasma cisplatin and selenium over time. Analysis of pharmacodynamic markers will be conducted using statistical methods appropriate for within-patient sequential analyses, such as repeated measures analysis of variance.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Placebo, Cisplatin, and Radiotherapy)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Placebo, Cisplatin, and Radiotherapy)
n=8 participants at risk
Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies
|
Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
n=10 participants at risk
Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Cardiac disorders
Ventricular tachycardia
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
General disorders
Mucosal inflammation
|
12.5%
1/8 • Number of events 3
|
10.0%
1/10 • Number of events 3
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Investigations
Blood creatine increased
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Investigations
Blood sodium abnormal
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Investigations
Haemoglobin decreased
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 3
|
10.0%
1/10 • Number of events 3
|
|
Nervous system disorders
Cerebrovascular accident
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
|
10.0%
1/10 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
12.5%
1/8 • Number of events 6
|
0.00%
0/10
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
Other adverse events
| Measure |
Arm I (Placebo, Cisplatin, and Radiotherapy)
n=8 participants at risk
Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
placebo: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies
|
Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
n=10 participants at risk
Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
selenomethionine: Given PO
cisplatin: Given IV
radiation therapy: Undergo radiotherapy
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
1/8 • Number of events 3
|
20.0%
2/10 • Number of events 9
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.0%
2/8 • Number of events 18
|
30.0%
3/10 • Number of events 27
|
|
Blood and lymphatic system disorders
White blood cell disorder
|
12.5%
1/8 • Number of events 3
|
10.0%
1/10 • Number of events 3
|
|
Cardiac disorders
Angina pectoris
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Ear and labyrinth disorders
Deafness
|
12.5%
1/8 • Number of events 3
|
10.0%
1/10 • Number of events 3
|
|
Ear and labyrinth disorders
Ear pain
|
25.0%
2/8 • Number of events 6
|
0.00%
0/10
|
|
Ear and labyrinth disorders
Hypoacusis
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Ear and labyrinth disorders
Tinnitus
|
12.5%
1/8 • Number of events 3
|
30.0%
3/10 • Number of events 12
|
|
Eye disorders
Diplopia
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Gastrointestinal disorders
Constipation
|
62.5%
5/8 • Number of events 24
|
60.0%
6/10 • Number of events 30
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 3
|
30.0%
3/10 • Number of events 21
|
|
Gastrointestinal disorders
Dry mouth
|
62.5%
5/8 • Number of events 15
|
50.0%
5/10 • Number of events 15
|
|
Gastrointestinal disorders
Dysphagia
|
62.5%
5/8 • Number of events 21
|
50.0%
5/10 • Number of events 15
|
|
Gastrointestinal disorders
Glossodynia
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Gastrointestinal disorders
Mouth ulceration
|
12.5%
1/8 • Number of events 3
|
10.0%
1/10 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
62.5%
5/8 • Number of events 24
|
80.0%
8/10 • Number of events 27
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/8
|
20.0%
2/10 • Number of events 6
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
12.5%
1/8 • Number of events 3
|
10.0%
1/10 • Number of events 3
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/8
|
10.0%
1/10 • Number of events 6
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
25.0%
2/8 • Number of events 9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • Number of events 3
|
20.0%
2/10 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8 • Number of events 9
|
20.0%
2/10 • Number of events 6
|
|
General disorders
Asthenia
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
General disorders
Fatigue
|
62.5%
5/8 • Number of events 21
|
60.0%
6/10 • Number of events 39
|
|
General disorders
Fibrosis
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
General disorders
Localised oedema
|
0.00%
0/8
|
20.0%
2/10 • Number of events 6
|
|
General disorders
Mucosal inflammation
|
50.0%
4/8 • Number of events 24
|
60.0%
6/10 • Number of events 30
|
|
General disorders
Oedema peripheral
|
12.5%
1/8 • Number of events 3
|
10.0%
1/10 • Number of events 3
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 3
|
10.0%
1/10 • Number of events 3
|
|
General disorders
Pyrexia
|
25.0%
2/8 • Number of events 6
|
20.0%
2/10 • Number of events 6
|
|
General disorders
Secretion discharge
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Infections and infestations
Infection
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Infections and infestations
Oral candidiasis
|
12.5%
1/8 • Number of events 3
|
10.0%
1/10 • Number of events 3
|
|
Infections and infestations
Perianal abscess
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
50.0%
4/8 • Number of events 15
|
30.0%
3/10 • Number of events 9
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Investigations
Blood bilirubin abnormal
|
0.00%
0/8
|
10.0%
1/10 • Number of events 6
|
|
Investigations
Blood creatine increased
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Investigations
Blood creatinine increased
|
12.5%
1/8 • Number of events 6
|
0.00%
0/10
|
|
Investigations
Blood sodium abnormal
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Investigations
Haemoglobin
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Investigations
Haemoglobin decreased
|
25.0%
2/8 • Number of events 9
|
40.0%
4/10 • Number of events 27
|
|
Investigations
Neutrophil count decreased
|
25.0%
2/8 • Number of events 6
|
10.0%
1/10 • Number of events 3
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • Number of events 3
|
20.0%
2/10 • Number of events 9
|
|
Investigations
Weight decreased
|
25.0%
2/8 • Number of events 6
|
20.0%
2/10 • Number of events 9
|
|
Investigations
White blood cell count decreased
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
4/8 • Number of events 18
|
30.0%
3/10 • Number of events 12
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 3
|
30.0%
3/10 • Number of events 9
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
2/8 • Number of events 15
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
2/8 • Number of events 6
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
1/8 • Number of events 3
|
10.0%
1/10 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
2/8 • Number of events 6
|
10.0%
1/10 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8 • Number of events 21
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
1/8 • Number of events 6
|
40.0%
4/10 • Number of events 18
|
|
Metabolism and nutrition disorders
Oral intake reduced
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Number of events 3
|
20.0%
2/10 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Nervous system disorders
Ageusia
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
|
20.0%
2/10 • Number of events 6
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Nervous system disorders
Dysgeusia
|
50.0%
4/8 • Number of events 12
|
60.0%
6/10 • Number of events 21
|
|
Nervous system disorders
Facial paresis
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 12
|
10.0%
1/10 • Number of events 3
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Renal and urinary disorders
Urinary retention
|
12.5%
1/8 • Number of events 6
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/8
|
20.0%
2/10 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 6
|
20.0%
2/10 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
25.0%
2/8 • Number of events 6
|
20.0%
2/10 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
25.0%
2/8 • Number of events 6
|
10.0%
1/10 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/8
|
50.0%
5/10 • Number of events 18
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
50.0%
4/8 • Number of events 18
|
60.0%
6/10 • Number of events 24
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Number of events 3
|
20.0%
2/10 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Erythema
|
50.0%
4/8 • Number of events 18
|
70.0%
7/10 • Number of events 30
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/8
|
10.0%
1/10 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 3
|
10.0%
1/10 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
|
Vascular disorders
Orthostatic hypotension
|
25.0%
2/8 • Number of events 6
|
0.00%
0/10
|
|
Vascular disorders
Thrombosis
|
12.5%
1/8 • Number of events 3
|
0.00%
0/10
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place