Trial Outcomes & Findings for Chemotherapy and Radiation Therapy (RT) With or Without Vandetanib in Treating Patients With High-Risk Stage III or Stage IV Head and Neck Cancer (NCT NCT00720083)
NCT ID: NCT00720083
Last Updated: 2015-11-17
Results Overview
This study terminated early with 34 subjects accrued out of 170 planned, therefore no analyses were performed.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
From randomization to date of failure (local, regional, or distant progression, or death) or last follow-up. Analysis occurs after 78 failures have been reported.
Results posted on
2015-11-17
Participant Flow
34 subjects were registered, after which 2 did not continue to randomization due to physician preference.
Participant milestones
| Measure |
RT + Cisplatin
Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
|
RT + Cisplatin + Vandetanib
Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
RT + Cisplatin
Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
|
RT + Cisplatin + Vandetanib
Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Ineligible
|
1
|
2
|
Baseline Characteristics
Chemotherapy and Radiation Therapy (RT) With or Without Vandetanib in Treating Patients With High-Risk Stage III or Stage IV Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
RT + Cisplatin
n=16 Participants
Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
|
RT + Cisplatin + Vandetanib
n=13 Participants
Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=99 Participants
|
53 years
n=107 Participants
|
57 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From randomization to date of failure (local, regional, or distant progression, or death) or last follow-up. Analysis occurs after 78 failures have been reported.This study terminated early with 34 subjects accrued out of 170 planned, therefore no analyses were performed.
Outcome measures
Outcome data not reported
Adverse Events
RT+ Cisplatin
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
RT + Cisplatin + Vandetanib
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RT+ Cisplatin
n=16 participants at risk
Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
|
RT + Cisplatin + Vandetanib
n=13 participants at risk
Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Oral pain
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Immune system disorders
Allergic reaction
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Infections and infestations - Other
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
Neutrophil count decreased
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
White blood cell decreased
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
Other adverse events
| Measure |
RT+ Cisplatin
n=16 participants at risk
Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
|
RT + Cisplatin + Vandetanib
n=13 participants at risk
Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
56.2%
9/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Blood and lymphatic system disorders
Hemolysis
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Ear and labyrinth disorders
Ear pain
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Ear and labyrinth disorders
Hearing impaired
|
31.2%
5/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Ear and labyrinth disorders
Tinnitus
|
18.8%
3/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Endocrine disorders
Hyperthyroidism
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Endocrine disorders
Hypothyroidism
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Eye disorders
Blurred vision
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Constipation
|
43.8%
7/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
46.2%
6/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Diarrhea
|
31.2%
5/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
30.8%
4/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Dry mouth
|
81.2%
13/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
76.9%
10/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
38.5%
5/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Dysphagia
|
81.2%
13/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
84.6%
11/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Mucositis oral
|
81.2%
13/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
76.9%
10/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Nausea
|
75.0%
12/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
46.2%
6/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Oral pain
|
18.8%
3/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
30.8%
4/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Vomiting
|
43.8%
7/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
46.2%
6/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
General disorders
Edema face
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
15.4%
2/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
General disorders
Edema limbs
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
General disorders
Fatigue
|
75.0%
12/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
38.5%
5/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
General disorders
Fever
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
23.1%
3/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
General disorders
Pain
|
25.0%
4/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Immune system disorders
Immune system disorders - Other
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Infections and infestations - Other
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Otitis externa
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Otitis media
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Skin infection
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
75.0%
12/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
53.8%
7/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
18.8%
3/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
38.5%
5/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
Alanine aminotransferase increased
|
18.8%
3/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
23.1%
3/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
Alkaline phosphatase increased
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
15.4%
2/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
Creatinine increased
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
23.1%
3/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
Lymphocyte count decreased
|
25.0%
4/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
15.4%
2/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
Neutrophil count decreased
|
43.8%
7/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
Platelet count decreased
|
18.8%
3/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
15.4%
2/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
Weight loss
|
37.5%
6/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
38.5%
5/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Investigations
White blood cell decreased
|
43.8%
7/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Anorexia
|
37.5%
6/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
15.4%
2/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
4/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.8%
3/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
23.1%
3/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
15.4%
2/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.8%
3/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
23.1%
3/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
31.2%
5/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
15.4%
2/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Neck soft tissue necrosis
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
18.8%
3/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Dysgeusia
|
56.2%
9/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
46.2%
6/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Headache
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
15.4%
2/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Neuralgia
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
23.1%
3/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
31.2%
5/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Seizure
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Syncope
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Psychiatric disorders
Depression
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
4/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
23.1%
3/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
18.8%
3/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
15.4%
2/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
30.8%
4/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
15.4%
2/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
25.0%
4/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
7.7%
1/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
12.5%
2/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
23.1%
3/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
31.2%
5/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
38.5%
5/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Hypertension
|
0.00%
0/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
23.1%
3/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Hypotension
|
6.2%
1/16
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
0.00%
0/13
Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology applied for non-SAE adverse events (AE).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place