Trial Outcomes & Findings for Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery (NCT NCT00113399)
NCT ID: NCT00113399
Last Updated: 2013-07-02
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
15 participants
Primary outcome timeframe
Date of death or last follow-up
Results posted on
2013-07-02
Participant Flow
Participant milestones
| Measure |
Re-irradiation Plus Concurrent Chemotherapy
Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. \[Data is reported for eligible patients with adverse event information, which is 6 patients.\]
|
Chemotherapy Alone
Select from one of the three standard chemotherapy regimens:
cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. \[Data is reported for eligible patients with adverse event information, which is 7 patients.\]
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Re-irradiation Plus Concurrent Chemotherapy
Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. \[Data is reported for eligible patients with adverse event information, which is 6 patients.\]
|
Chemotherapy Alone
Select from one of the three standard chemotherapy regimens:
cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. \[Data is reported for eligible patients with adverse event information, which is 7 patients.\]
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Complete Response
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Re-irradiation Plus Concurrent Chemotherapy
n=6 Participants
Radiation Therapy on weeks 1, 3, 5, and 7 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. \[Data is reported for eligible patients with on-study information, which is 6 patients.\]
|
Chemotherapy Alone
n=7 Participants
Select from one of the three standard chemotherapy regimens:
cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. \[Data is reported for eligible patients with on-study information, which is 7 patients.\]
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56 years
n=99 Participants
|
57 years
n=107 Participants
|
57 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Date of death or last follow-upPopulation: This study terminated early with 15 subjects out of 240 subjects accrued, therefore no analyses were performed.
Outcome measures
Outcome data not reported
Adverse Events
Re-irradiation Plus Concurrent Chemotherapy
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Chemotherapy Alone
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Re-irradiation Plus Concurrent Chemotherapy
n=6 participants at risk
Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. \[Data is reported for eligible patients with adverse event information, which is 6 patients.\]
|
Chemotherapy Alone
n=7 participants at risk
Select from one of the three standard chemotherapy regimens:
cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. \[Data is reported for eligible patients with adverse event information, which is 7 patients.\]
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Infections and infestations
Infections and infestations - Other
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Investigations
White blood cell decreased
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
Other adverse events
| Measure |
Re-irradiation Plus Concurrent Chemotherapy
n=6 participants at risk
Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. \[Data is reported for eligible patients with adverse event information, which is 6 patients.\]
|
Chemotherapy Alone
n=7 participants at risk
Select from one of the three standard chemotherapy regimens:
cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. \[Data is reported for eligible patients with adverse event information, which is 7 patients.\]
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
6/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
71.4%
5/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Ear and labyrinth disorders
Hearing impaired
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
42.9%
3/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Dry mouth
|
66.7%
4/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
3/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Esophageal pain
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Esophagitis
|
50.0%
3/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
3/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
71.4%
5/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Oral cavity fistula
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Oral pain
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
71.4%
5/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
General disorders
Edema face
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
General disorders
Fatigue
|
83.3%
5/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
57.1%
4/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
General disorders
Fever
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
General disorders
Pain
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Infections and infestations
Infections and infestations - Other
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Infections and infestations
Lung infection
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Investigations
Alkaline phosphatase increased
|
83.3%
5/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Investigations
Creatinine increased
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Investigations
Investigations - Other
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Investigations
Platelet count decreased
|
66.7%
4/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
42.9%
3/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Investigations
Weight loss
|
50.0%
3/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Investigations
White blood cell decreased
|
83.3%
5/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
83.3%
5/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
57.1%
4/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
50.0%
3/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
83.3%
5/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
83.3%
5/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
57.1%
4/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
50.0%
3/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
3/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
3/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
83.3%
5/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
42.9%
3/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Metabolism and nutrition disorders
Iron overload
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Nervous system disorders
Headache
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
57.1%
4/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Psychiatric disorders
Depression
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
33.3%
2/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
28.6%
2/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
16.7%
1/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
0.00%
0/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
14.3%
1/7
Per the protocol, toxicity data was collected via CTCAE 3.0, then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing \> 1 of a given SAE are counted only once for that SAE. Subjects experiencing \> 1 of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place