Trial Outcomes & Findings for Nivolumab + Chemoradiation in Stage II-IVB Nasopharyngeal Carcinoma (NPC) (NCT NCT03267498)
NCT ID: NCT03267498
Last Updated: 2026-01-12
Results Overview
The rate of completion of all adjuvant therapy by patients treated at the maximum tolerated dose (MTD) schedule will be determined and compared to a historical control rate of 52%, the rate of completion of a standard adjuvant cisplatin-based platform to determine feasibility of study treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2026-01-12
Participant Flow
Participant milestones
| Measure |
Nivolumab + Chemoradiation
Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy once a day (QD) 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab + Chemoradiation in Stage II-IVB Nasopharyngeal Carcinoma (NPC)
Baseline characteristics by cohort
| Measure |
Nivolumab + Chemoradiation
n=40 Participants
Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy QD 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
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|---|---|
|
Age, Customized
30-39 years old
|
3 Participants
n=210 Participants
|
|
Age, Customized
40-49 years old
|
11 Participants
n=210 Participants
|
|
Age, Customized
50-59 years old
|
11 Participants
n=210 Participants
|
|
Age, Customized
60-69 years old
|
13 Participants
n=210 Participants
|
|
Age, Customized
70-79 years old
|
2 Participants
n=210 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=210 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=210 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=210 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=210 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=210 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=210 Participants
|
|
Region of Enrollment
Singapore
|
15 participants
n=210 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearThe rate of completion of all adjuvant therapy by patients treated at the maximum tolerated dose (MTD) schedule will be determined and compared to a historical control rate of 52%, the rate of completion of a standard adjuvant cisplatin-based platform to determine feasibility of study treatment
Outcome measures
| Measure |
Nivolumab + Chemoradiation
n=40 Participants
Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy QD 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Rate of Completion of All Adjuvant Immunotherapy
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 1 year after completion of treatmentThe ORR is based on the best overall response (BOR) recorded from the first day of treatment until time of assessment. The percentages of patients with a best overall response rate of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be determined as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Outcome measures
| Measure |
Nivolumab + Chemoradiation
n=40 Participants
Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy QD 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
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|---|---|
|
Overall Response Rate (ORR)
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 1 year after completion of treatmentAdverse events will be classified using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) version 5.0 by the investigator assessment and reported by frequency of Adverse Events (AEs) attributed as definitely, probably, or possibly related to the study interventions.
Outcome measures
| Measure |
Nivolumab + Chemoradiation
n=40 Participants
Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy QD 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
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|---|---|
|
Number of Treatment-related Adverse Events (AEs)
Arthralgia
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Bloating
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Blurred vision
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Burn
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Cardiac disorders , Other
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Chills
|
4 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Cholesterol high
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Constipation
|
14 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Cough
|
4 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Dehydration
|
7 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Dermatitis radiation
|
15 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Diarrhea
|
4 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Dizziness
|
8 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Dry eye
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Dry mouth
|
42 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Dry skin
|
3 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Dysgeusia
|
42 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Dyspepsia
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Dysphagia
|
19 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Dysphasia
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Dyspnea
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Ear and labyrinth disorders, Other
|
3 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Ear pain
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Epistaxis
|
4 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Eye disorders - Other, specify
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Eye pain
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Fatigue
|
30 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Fever
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Gastritis
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Gastroesophageal reflux disease
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Gastrointestinal disorders, Other
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Infections and infestations - Other, specify
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Insomnia
|
5 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Investigations - Other, specify
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Keratitis
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Lethargy
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Lymph node pain
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Lymphedema
|
4 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Lymphocyte count decreased
|
38 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Mucositis oral
|
43 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Muscle weakness lower limb
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Myalgia
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Nasal congestion
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Nausea
|
36 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Neck edema
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Neck pain
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Nervous system disorders, Other
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Neutrophil count decreased
|
15 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Non-cardiac chest pain
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Oral pain
|
4 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Oropharyngeal pain
|
9 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Otitis media
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Pain
|
12 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Pain in extremity
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Paresthesia
|
3 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Peripheral sensory neuropathy
|
5 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Platelet count decreased
|
19 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Pruritus
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Psychiatric disorders, Other
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Rash acneiform
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Rash maculo-papular
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Alkaline phosphatase increased
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Allergic rhinitis
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Alopecia
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Anemia
|
11 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Anorexia
|
18 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Alanine aminotransferase increased
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
General disorders and administration site conditions - Other, specify
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Gingival pain
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Headache
|
5 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hearing impaired
|
10 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hyperhidrosis
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hyperkalemia
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hypermagnesemia
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hypernatremia
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hypertension
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hyperthyroidism
|
3 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hypoalbuminemia
|
3 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hypocalcemia
|
4 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hypokalemia
|
8 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hypomagnesemia
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hyponatremia
|
15 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hypophosphatemia
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hypotension
|
3 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Hypothyroidism
|
7 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Respiratory, thoracic and mediastinal disorders, Other
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Sepsis
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Shingles
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Sinusitis
|
4 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Skin and subcutaneous tissue disorders - Other, specify
|
25 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Skin hyperpigmentation
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Skin infection
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Skin ulceration
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Sore throat
|
10 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Thrush
|
10 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Tinnitus
|
18 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Tremor
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Urticaria
|
2 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Voice alteration
|
1 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Vomiting
|
7 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
Weight loss
|
44 adverse events
|
|
Number of Treatment-related Adverse Events (AEs)
White blood cell decreased
|
17 adverse events
|
SECONDARY outcome
Timeframe: Up to 1 year after completion of treatmentDuration of LRC will be calculated as 1+ the number of days from the first day of treatment to time of documented locoregional clinical or radiographic relapse, progression or death due to any cause. For patients who continue treatment post-progression, the date of clinical or radiographic relapse or progression will be used for analysis. The Kaplan-Meier analysis will be used to calculate the mean LRC rate with full range.
Outcome measures
| Measure |
Nivolumab + Chemoradiation
n=40 Participants
Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy QD 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
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|---|---|
|
Mean Loco-regional Control (LRC) Rate
|
96 days
Interval 89.0 to 99.6
|
SECONDARY outcome
Timeframe: Up to 1 year after completion of treatmentPopulation: As there were no participants with disease progression in a distant metastatic site, no data were collected for this outcome measure.
Time to DM will be calculated as 1+ the number of days from the first day of treatment to documented clinical or radiographic progression at a distant metastatic site, or death due to any cause. Pathologic confirmation is not required to document the date of distant progression. For patients who continue treatment post-progression, the date of clinical or radiographic progression will be used for analysis. The Kaplan-Meier analysis will be used to calculate the mean DM rate with full range.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 year after completion of treatmentThe FACT-NP is a self-report instrument that measures multidimensional quality of life (QOL) in patients with Nasopharyngeal cancer-specific scale. The FACT-NP consists of 43 questions that address physical, social, emotional, and functional well-being, with additional specific questions relevant to persons with nasopharyngeal cancers. Each item has a score range of 0 (Not at all) to 4 (Very much). For the 37 general health and head and neck cancer sections, the raw score range is 0-148, with the higher scores indicating better QOL reported by the participant. The 6 remaining questions for the nasopharyngeal cancers also fall on the same range of 0 to 4, with a raw total score range of 0-24, but on this subscale, lower scores indicate a higher QOL.
Outcome measures
| Measure |
Nivolumab + Chemoradiation
n=40 Participants
Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy QD 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Mean Change in Scores on the Functional Assessment of Cancer Therapy - Nasopharyngeal Cancer (FACT-NP)
|
3.7 scores on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Up to 1 year after completion of treatmentAcute toxicity rates will be reported and classified according to CTCAE version 5 and include immune-related AEs
Outcome measures
| Measure |
Nivolumab + Chemoradiation
n=40 Participants
Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy QD 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Acute Toxicities
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 1 year after completion of treatmentLate toxicity rates will be reported and classified according to CTCAE version 5 and include immune-related AEs
Outcome measures
| Measure |
Nivolumab + Chemoradiation
n=40 Participants
Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy QD 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Late Toxicities
|
100 percentage of participants
|
Adverse Events
Nivolumab + Chemoradiation
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nivolumab + Chemoradiation
n=40 participants at risk
Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy QD 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Vascular disorders
Hypotension
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Cardiac disorders
Myocardial infarction
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
Other adverse events
| Measure |
Nivolumab + Chemoradiation
n=40 participants at risk
Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy QD 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
General disorders
Fever
|
10.0%
4/40 • Number of events 4 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 3 • Up to 1 year after completion of treatment, approximately 18 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
General disorders
Neck edema
|
7.5%
3/40 • Number of events 3 • Up to 1 year after completion of treatment, approximately 18 months
|
|
General disorders
Non-cardiac chest pain
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
General disorders
Pain
|
17.5%
7/40 • Number of events 12 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Immune system disorders
Allergic Reaction
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Infections and infestations
Herpes simplex reactivation
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Vascular disorders
Lymphedema
|
10.0%
4/40 • Number of events 4 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
17.5%
7/40 • Number of events 8 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Infections and infestations
Otitis media
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Infections and infestations
Papulopustular rash
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Infections and infestations
Shingles
|
7.5%
3/40 • Number of events 3 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Infections and infestations
Sinusitis
|
10.0%
4/40 • Number of events 4 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Infections and infestations
Skin infection
|
2.5%
1/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Infections and infestations
Thrush
|
27.5%
11/40 • Number of events 12 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Injury, poisoning and procedural complications
Burn
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
40.0%
16/40 • Number of events 16 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Injury, poisoning and procedural complications
Fracture
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
2/40 • Number of events 3 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Investigations
Alkaline phosphatase increased
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Investigations
Aspartate aminotransferase increased
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Investigations
Blood bilirubin increased
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Investigations
Cholesterol high
|
7.5%
3/40 • Number of events 4 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Investigations
Creatinine increased
|
2.5%
1/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Investigations
Investigations - Other, specify
|
7.5%
3/40 • Number of events 6 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Investigations
Lymphocyte count decreased
|
27.5%
11/40 • Number of events 39 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Investigations
Neutrophil count decreased
|
30.0%
12/40 • Number of events 17 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Investigations
Platelet count decreased
|
27.5%
11/40 • Number of events 21 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Investigations
Weight loss
|
60.0%
24/40 • Number of events 47 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Investigations
White blood cell decreased
|
12.5%
5/40 • Number of events 17 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Metabolism and nutrition disorders
Anorexia
|
37.5%
15/40 • Number of events 18 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
17.5%
7/40 • Number of events 7 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.5%
3/40 • Number of events 3 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.5%
1/40 • Number of events 3 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.5%
3/40 • Number of events 5 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.5%
3/40 • Number of events 9 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
4/40 • Number of events 15 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders, Other
|
10.0%
4/40 • Number of events 4 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Nervous system disorders
Anosmia
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Nervous system disorders
Dizziness
|
25.0%
10/40 • Number of events 14 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Nervous system disorders
Dysgeusia
|
77.5%
31/40 • Number of events 42 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Nervous system disorders
Dysphasia
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Nervous system disorders
Headache
|
17.5%
7/40 • Number of events 7 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Nervous system disorders
Lethargy
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Nervous system disorders
Nervous system disorders, Other
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Nervous system disorders
Paresthesia
|
7.5%
3/40 • Number of events 3 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
4/40 • Number of events 5 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Nervous system disorders
Tremor
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Psychiatric disorders
Depression
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Psychiatric disorders
Insomnia
|
15.0%
6/40 • Number of events 7 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Psychiatric disorders
Psychiatric disorders, Other
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
8/40 • Number of events 8 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
4/40 • Number of events 5 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.5%
3/40 • Number of events 4 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
22.5%
9/40 • Number of events 9 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders, Other
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
22.5%
9/40 • Number of events 10 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
2/40 • Number of events 3 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
45.0%
18/40 • Number of events 29 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Dysphagia
|
37.5%
15/40 • Number of events 19 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Gastritis
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders, Other
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Gingival pain
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Mucositis oral
|
70.0%
28/40 • Number of events 45 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Nausea
|
67.5%
27/40 • Number of events 36 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Oral pain
|
7.5%
3/40 • Number of events 4 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
8/40 • Number of events 8 • Up to 1 year after completion of treatment, approximately 18 months
|
|
General disorders
Chills
|
12.5%
5/40 • Number of events 5 • Up to 1 year after completion of treatment, approximately 18 months
|
|
General disorders
Fatigue
|
62.5%
25/40 • Number of events 30 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Blood and lymphatic system disorders
Anemia
|
17.5%
7/40 • Number of events 11 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Cardiac disorders
Chest pain - cardiac
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Cardiac disorders
Sinus tachycardia
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Cardiac disorders
Cardiac disorders , Other
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders, Other
|
7.5%
3/40 • Number of events 3 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Ear and labyrinth disorders
Ear pain
|
10.0%
4/40 • Number of events 4 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
25.0%
10/40 • Number of events 10 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Ear and labyrinth disorders
Tinnitus
|
47.5%
19/40 • Number of events 20 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Endocrine disorders
Hyperthyroidism
|
7.5%
3/40 • Number of events 3 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Endocrine disorders
Hypothyroidism
|
15.0%
6/40 • Number of events 7 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Eye disorders
Blurred vision
|
10.0%
4/40 • Number of events 4 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Eye disorders
Dry eye
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Eye disorders
Eye disorders - Other, specify
|
10.0%
4/40 • Number of events 5 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Eye disorders
Eye pain
|
5.0%
2/40 • Number of events 2 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Eye disorders
Keratitis
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Bloating
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Constipation
|
60.0%
24/40 • Number of events 31 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
15.0%
6/40 • Number of events 7 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Dry mouth
|
75.0%
30/40 • Number of events 43 • Up to 1 year after completion of treatment, approximately 18 months
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
1/40 • Number of events 1 • Up to 1 year after completion of treatment, approximately 18 months
|
Additional Information
Dr. Sue Yom, MD PhD, MAS
University of California, San Francisco
Phone: (415) 353-9893
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place