Trial Outcomes & Findings for Low Dose Arsenic Trioxide as a Potential Chemotherapy Protector (NCT NCT01428128)
NCT ID: NCT01428128
Last Updated: 2017-12-13
Results Overview
A main objective of this trial is to find the dose of arsenic that blocks the activation of p53. Blockage will reduce the amount of p53 production as measured by Western Blot.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Day 1 of chemotherapy
Results posted on
2017-12-13
Participant Flow
Recruitment took place from April 2011 to November 2012. Patients were recruited from Medical Oncology clinic and due to receive standard of care chemotherapy.
No baseline p52 activation in peripheral lymphocytes in culture, but p53 activation inducible upon radiation in culture.
Participant milestones
| Measure |
Arsenic Trioxide
Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Arsenic Trioxide
Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Screen failure by p53
|
10
|
|
Overall Study
Received Neulasta in one cycle
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Low Dose Arsenic Trioxide as a Potential Chemotherapy Protector
Baseline characteristics by cohort
| Measure |
Arsenic Trioxide
n=33 Participants
Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
|
|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 of chemotherapyA main objective of this trial is to find the dose of arsenic that blocks the activation of p53. Blockage will reduce the amount of p53 production as measured by Western Blot.
Outcome measures
| Measure |
Arsenic Trioxide
n=33 Participants
Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
|
|---|---|
|
Dose of Arsenic That Blocks Activation of p53
|
0.005 mg/kg
|
SECONDARY outcome
Timeframe: Day 9 of chemotherapyPopulation: Data was not collected from CBC at 9 days
Another objective of this trial is to assess if arsenic protects the blood counts that are adversely affected by chemotherapy
Outcome measures
Outcome data not reported
Adverse Events
Arsenic Trioxide
Serious events: 9 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arsenic Trioxide
n=35 participants at risk
Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
|
|---|---|
|
Vascular disorders
hypotension
|
2.9%
1/35 • Number of events 1 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
2.9%
1/35 • Number of events 1 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
General disorders
infusion site extravasation
|
2.9%
1/35 • Number of events 1 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Infections and infestations
device related infection
|
5.7%
2/35 • Number of events 2 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
General disorders
non-cardiac chest pain
|
2.9%
1/35 • Number of events 1 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
2.9%
1/35 • Number of events 1 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Infections and infestations
infection, other
|
2.9%
1/35 • Number of events 1 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Infections and infestations
lung infection
|
5.7%
2/35 • Number of events 2 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Gastrointestinal disorders
ascites
|
2.9%
1/35 • Number of events 1 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Gastrointestinal disorders
esophageal hemorrhage
|
2.9%
1/35 • Number of events 1 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Metabolism and nutrition disorders
dehydration
|
2.9%
1/35 • Number of events 1 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Infections and infestations
sepsis
|
2.9%
1/35 • Number of events 1 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
Other adverse events
| Measure |
Arsenic Trioxide
n=35 participants at risk
Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
4/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Investigations
Alanine aminotransferase increased
|
42.9%
15/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Investigations
Alkaline phosphatase increased
|
40.0%
14/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Immune system disorders
Allergic reacton
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
62.9%
22/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Blood and lymphatic system disorders
Anemia
|
82.9%
29/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Metabolism and nutrition disorders
Anorexia
|
22.9%
8/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Psychiatric disorders
Anxiety
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.9%
8/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Investigations
Aspatrate aminotransferase increased
|
45.7%
16/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Investigations
Blood bilirubin increased
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Eye disorders
Blurred vision
|
11.4%
4/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Reproductive system and breast disorders
Breast pain
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
General disorders
Chills
|
14.3%
5/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Gastrointestinal disorders
Constipation
|
34.3%
12/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
5/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Investigations
Creatinine increased
|
11.4%
4/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Psychiatric disorders
Depression
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
7/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Nervous system disorders
Dizziness
|
20.0%
7/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Gastrointestinal disorders
Dry mouth
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.1%
6/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Nervous system disorders
Dysgeusia
|
34.3%
12/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.4%
4/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.1%
6/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Ear and labyrinth disorders
Ear pain
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Investigations
EKG QT corrected interval prolongation
|
40.0%
14/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
General disorders
Fatigue
|
71.4%
25/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
5/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
General disorders
Fever
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
General disorders
Flu like symptoms
|
20.0%
7/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Vascular disorders
Flushing
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Increased appetite
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Nervous system disorders
Headache
|
22.9%
8/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Vascular disorders
Hot flashes
|
20.0%
7/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Vascular disorders
Hypertension
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
60.0%
21/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
54.3%
19/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
31.4%
11/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
17.1%
6/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.7%
9/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Vascular disorders
Hypotension
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
General disorders
Infusion related reaction
|
11.4%
4/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Investigations
INR increased
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Psychiatric disorders
Insomnia
|
28.6%
10/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
11.4%
4/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Infections and infestations
Lip infection
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
General disorders
Localized edema
|
17.1%
6/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Investigations
Lymphocyte count decreased
|
82.9%
29/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Nervous system disorders
Memory impairment
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Infections and infestations
Mucosal infection
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Gastrointestinal disorders
Mucositis oral
|
28.6%
10/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
22.9%
8/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Infections and infestations
Nail infection
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Gastrointestinal disorders
Nausea
|
77.1%
27/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Nervous system disorders
Nervous System disorders-Other, Change in sense of smell
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Nervous system disorders
Neuralgia
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Investigations
Neutrophil count decreased
|
91.4%
32/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
General disorders
Non-cardiac chest pain
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
General disorders
Pain
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.4%
4/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
17.1%
6/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Cardiac disorders
Palpitations
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
42.9%
15/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Investigations
Platelet count decreased
|
31.4%
11/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
11.4%
4/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.4%
4/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
17.1%
6/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders-Other, Rash, not specified
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
14.3%
5/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Nervous system disorders
Tremor
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Infections and infestations
Upper respiratory infection
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Renal and urinary disorders
Urinary frequency
|
8.6%
3/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
7/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Eye disorders
Watering eyes
|
14.3%
5/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Investigations
Weight loss
|
11.4%
4/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.7%
2/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
|
Investigations
White blood cell decreased
|
100.0%
35/35 • Average time on study: 3.5 months. Reported Adverse Events (AEs) included events starting from consent to the end of final cycle of chemotherapy. Average time on study was 3.5 months with range from 2 to 6 months.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
|
Additional Information
Chul S. Ha, MD, Professor and Chair
The University of Texas Health Science Center at San Antonio, Department of Radiation Oncology
Phone: 210-450-1109
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place