Trial Outcomes & Findings for Amivantamab in Adenoid Cystic Carcinoma (NCT NCT05074940)
NCT ID: NCT05074940
Last Updated: 2026-05-08
Results Overview
To determine the overall response rate in patients with recurrent and metastatic adenoid cystic carcinoma treated with amivantamab. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
2 years
Results posted on
2026-05-08
Participant Flow
Twenty-six patients were screened for eligibility, and 5 patients did not meet screening criteria. Twenty-one patients began protocol treatment and were included in the safety set, while 3 patients were unevaluable and excluded from efficacy analyses for discontinuing amivantamab treatment before first restaging
Participant milestones
| Measure |
Amivantamab
Amivantamab weekly for the first cycle and biweekly thereafter.
Amivantamab: Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Amivantamab in Adenoid Cystic Carcinoma
Baseline characteristics by cohort
| Measure |
Amivantamab
n=21 Participants
Amivantamab weekly for the first cycle and biweekly thereafter.
Amivantamab: Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
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|---|---|
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Age, Continuous
|
61 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=41 Participants
|
|
Primary site of disease
Major salivary gland
|
6 Participants
n=41 Participants
|
|
Primary site of disease
Minor salivary gland
|
11 Participants
n=41 Participants
|
|
Primary site of disease
Other glandular sites
|
4 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 3 patients were unevaluable and excluded from efficacy analyses for discontinuing amivantamab treatment before first restaging. Thus, 18 subjects were included for analyses.
To determine the overall response rate in patients with recurrent and metastatic adenoid cystic carcinoma treated with amivantamab. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
Outcome measures
| Measure |
Amivantamab
n=18 Participants
Amivantamab weekly for the first cycle and biweekly thereafter.
Amivantamab: Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
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|---|---|
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Overall Response Rate Measured by RECIST Criteria
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 27 monthsPopulation: 3 patients were unevaluable and excluded from efficacy analyses for discontinuing amivantamab treatment before first restaging. Thus, 18 subjects were included for analyses.
To determine the progression free survival with recurrent and metastatic adenoid cystic carcinoma treated with amivantamab.
Outcome measures
| Measure |
Amivantamab
n=18 Participants
Amivantamab weekly for the first cycle and biweekly thereafter.
Amivantamab: Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
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|---|---|
|
Progression Free Survival -Measured as Time of Treatment Allocation to Confirmed Progressive Disease or Death.
|
4.6 months
Interval 1.9 to 7.8
|
SECONDARY outcome
Timeframe: Up to 16 months regardless of attribution should be collected continuously during the treatment period and for a minimum of 30 days following the last dose of study treatment.Population: Any subject that had at least one adverse event will be counted.
To determine safety of amivantamab in patients with recurrent and metastatic adenoid cystic carcinoma as measured by CTCAE v5. Any subject that had at least one adverse event will be counted.
Outcome measures
| Measure |
Amivantamab
n=21 Participants
Amivantamab weekly for the first cycle and biweekly thereafter.
Amivantamab: Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
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|---|---|
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Number of Participants With Adverse Events
|
21 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: Of the available data, the number of subjects with a genetic mutation were reported.
To determine the molecular signatures of response and resistance to amivantamab via molecular signatures of response and resistance- measured by comprehensive analysis of Transcriptome Sequencing
Outcome measures
| Measure |
Amivantamab
n=20 Participants
Amivantamab weekly for the first cycle and biweekly thereafter.
Amivantamab: Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
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|---|---|
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Number of Participants With a Genetic Mutation
|
14 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: 19 patients with evaluable inventory data
The FACT HN is a patient reported outcome (PRO) measure that assesses health related quality of life in patients with head and neck cancer. It evaluates general cancer related quality of life as well as symptoms and concerns specific to head and neck cancer. The total score range is 0 - 144, with higher scores reflecting more positive perceptions across areas of well-being. A difference score from end of treatment and pre-treatment was calculated.
Outcome measures
| Measure |
Amivantamab
n=19 Participants
Amivantamab weekly for the first cycle and biweekly thereafter.
Amivantamab: Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
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|---|---|
|
Quality of Life - Measured Via FACT-HN
|
-0.7 units on a scale
Standard Deviation 8.4
|
Adverse Events
Amivantamab
Serious events: 7 serious events
Other events: 21 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Amivantamab
n=21 participants at risk
Amivantamab weekly for the first cycle and biweekly thereafter.
Amivantamab: Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
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|---|---|
|
Infections and infestations
Cerebral abscess
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Eye disorders
Diplopia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Dysphagia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Encephalopathy
|
4.8%
1/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Eye disorders
Extraocular muscle paresis
|
4.8%
1/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.5%
2/21 • Number of events 4 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Infections and infestations
Joint infection
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Musculoskeletal and connective tissue disorders
Olecranon bursitis
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
General disorders
Pain
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Presyncope
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
Other adverse events
| Measure |
Amivantamab
n=21 participants at risk
Amivantamab weekly for the first cycle and biweekly thereafter.
Amivantamab: Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
|
|---|---|
|
General disorders
Chills
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Eye disorders
Conjunctivitis
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
3/21 • Number of events 5 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.0%
4/21 • Number of events 4 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Infections and infestations
COVID-19
|
19.0%
4/21 • Number of events 4 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
2/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Psychiatric disorders
Depression
|
19.0%
4/21 • Number of events 4 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
2/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Eye disorders
Diplopia
|
9.5%
2/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Dizziness
|
23.8%
5/21 • Number of events 5 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Dry mouth
|
19.0%
4/21 • Number of events 4 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
General disorders
Neck edema
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Dry nares
|
4.8%
1/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.8%
5/21 • Number of events 7 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Dysgeusia
|
14.3%
3/21 • Number of events 3 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.5%
2/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
3/21 • Number of events 3 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
6/21 • Number of events 7 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Ear and labyrinth disorders
Ear fullness
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
General disorders
Edema face
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
General disorders
Edema limbs
|
19.0%
4/21 • Number of events 6 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
General disorders
Edema trunk
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Encephalopathy
|
4.8%
1/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.0%
4/21 • Number of events 7 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Erythema- posterior oropharyngeal
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Ear and labyrinth disorders
Eustachian tube disorder
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Eye disorders
Extraocular muscle paresis
|
4.8%
1/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Injury, poisoning and procedural complications
Fall
|
19.0%
4/21 • Number of events 5 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
General disorders
Fatigue
|
85.7%
18/21 • Number of events 22 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
General disorders
Fever
|
9.5%
2/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Vascular disorders
Flushing
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
General disorders
Gait disturbance
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.5%
2/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
General disorders
Gout
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Headache
|
19.0%
4/21 • Number of events 6 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Renal and urinary disorders
Hematuria
|
14.3%
3/21 • Number of events 4 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Hemorrhoids
|
14.3%
3/21 • Number of events 3 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Hyperosmia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
28.6%
6/21 • Number of events 23 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
7/21 • Number of events 19 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Hypochloremia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
6/21 • Number of events 7 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.5%
2/21 • Number of events 3 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
7/21 • Number of events 16 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
47.6%
10/21 • Number of events 21 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Vascular disorders
Hypotension
|
23.8%
5/21 • Number of events 5 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
3/21 • Number of events 7 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
76.2%
16/21 • Number of events 20 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Psychiatric disorders
Insomnia
|
23.8%
5/21 • Number of events 5 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Infections and infestations
Joint infection
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Injury, poisoning and procedural complications
Laceration to lip
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
General disorders
Localized edema
|
14.3%
3/21 • Number of events 3 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
General disorders
Malaise
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Mucositis oral
|
28.6%
6/21 • Number of events 10 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Nausea
|
23.8%
5/21 • Number of events 5 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
2/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Acneiform rash
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Investigations
Alanine aminotransferase increased
|
23.8%
5/21 • Number of events 9 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Investigations
Alkaline phosphatase increased
|
42.9%
9/21 • Number of events 12 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
9.5%
2/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Anal fissure
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
7/21 • Number of events 11 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Metabolism and nutrition disorders
Anorexia
|
23.8%
5/21 • Number of events 8 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Psychiatric disorders
Anxiety
|
14.3%
3/21 • Number of events 3 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
3/21 • Number of events 8 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Cardiac disorders
Atrial fibrillation
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.8%
5/21 • Number of events 6 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Eye disorders
Blurred vision
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Infections and infestations
Cerebral abscess
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
General disorders
Non-cardiac chest pain
|
9.5%
2/21 • Number of events 4 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Musculoskeletal and connective tissue disorders
Olecranon bursitis
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
14.3%
3/21 • Number of events 3 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Oral pain
|
14.3%
3/21 • Number of events 3 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Infections and infestations
Otitis media
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
14.3%
3/21 • Number of events 4 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Infections and infestations
Papulopustular rash
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Paresthesia
|
9.5%
2/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Infections and infestations
Paronychia
|
33.3%
7/21 • Number of events 19 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.8%
1/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Investigations
Platelet count decreased
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.5%
2/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Presyncope
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Proctitis
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Rash (face/abdomen)
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Rash (feet)
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Rash (scalp)
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
85.7%
18/21 • Number of events 35 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Rectal fissure
|
4.8%
1/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Rectal pain
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Musculoskeletal and connective tissue disorders
Rib pain
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Scalp dermititis
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Infections and infestations
Sepsis
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
7/21 • Number of events 10 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Infections and infestations
Sinusitis
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Skin splitting/cracking (finger)
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Skin splitting/cracking/peeling (feet)
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Skin splitting/cracking/peeling (fingertips)
|
28.6%
6/21 • Number of events 7 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Skin splitting/cracking/peeling (lips)
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Spinal cord compression
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
Splitting skin
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Eye disorders
Strabismus
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Injury, poisoning and procedural complications
Stubbed toe
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Vascular disorders
Swelling at venous access site
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Syncope
|
9.5%
2/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Vascular disorders
Thromboembolic event
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Tongue swelling
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Nervous system disorders
Tremor
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
General disorders
Tumor pain
|
4.8%
1/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Skin and subcutaneous tissue disorders
|
4.8%
1/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Renal and urinary disorders
Urinary retention
|
4.8%
1/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Infections and infestations
Urinary tract infection
|
9.5%
2/21 • Number of events 2 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Eye disorders
Visual change
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Investigations
Weight loss
|
28.6%
6/21 • Number of events 11 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.8%
1/21 • Number of events 1 • Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months
They do not differ.
|
Additional Information
Trisha Wise-Draper M.D., Ph.D.
University of Cincinnati Cancer Center
Phone: (513) 558-2826
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place