Trial Outcomes & Findings for BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study (NCT NCT01744353)
NCT ID: NCT01744353
Last Updated: 2020-02-17
Results Overview
MTD (Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion) was defined by protocol documented and predefined DLT's in 3 dose levels.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
For up to 30 days post completing drug, an expected average of 6 months
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
Experimental: Dose Level 1
Abraxane 125 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
|
Experimental: Dose Level 2/ MTD
Abraxane 150 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
|
Experimental: Dose Level 3
Abraxane 175 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
26
|
3
|
|
Overall Study
COMPLETED
|
6
|
26
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study
Baseline characteristics by cohort
| Measure |
Experimental: Dose Level 3
n=3 Participants
Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane
|
Total
n=35 Participants
Total of all reporting groups
|
Experimental: Dose Level 1
n=6 Participants
Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane
|
Experimental: Dose Level 2/ MTD
n=26 Participants
Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
3 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
3 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
|
Age, Continuous
|
63.33 years
n=27 Participants
|
61.85 years
n=483 Participants
|
58.83 years
n=93 Participants
|
63.38 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
5 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
1 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=27 Participants
|
35 participants
n=483 Participants
|
6 participants
n=93 Participants
|
26 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: For up to 30 days post completing drug, an expected average of 6 monthsMTD (Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion) was defined by protocol documented and predefined DLT's in 3 dose levels.
Outcome measures
| Measure |
Experimental: Dose Level 1
n=6 Participants
Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane
|
Experimental: Dose Level 2/ MTD
n=26 Participants
Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane
|
Experimental: Dose Level 3
n=3 Participants
Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxan
|
|---|---|---|---|
|
Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer.
|
1 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: pre-drug until disease progression, whichever comes first, for an expected average of 6 monthsData below summarizes number of patients who experienced partial response. Partial response evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 Response Criteria Partial Response (PR) At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
Outcome measures
| Measure |
Experimental: Dose Level 1
n=6 Participants
Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane
|
Experimental: Dose Level 2/ MTD
n=26 Participants
Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxane
|
Experimental: Dose Level 3
n=3 Participants
Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
Other Names:
5-FU infusion, leuocovorin, oxaliplatin, Abraxan
|
|---|---|---|---|
|
Response Rate (if Patient's Tumor(s)Are Progressing or Being Controlled) Following Treatment With FOLFOX-A for Patients With Newly Diagnosed, Advanced Pancreatic Cancer.
|
3 participants
|
17 participants
|
1 participants
|
Adverse Events
FOLFOX- A
Serious events: 19 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FOLFOX- A
n=35 participants at risk
FOLFOX-A Dose levels -1, 1, 2, 3: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue until level 3 provided that the MTD has not been reached. If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If dose level 1 is not tolerable then dose level -1 will be investigated. Once the MTD is found, the Principal Investigator will determine which dose should be assessed futher and an additional 10 patients will be treated.
FOLFOX-A: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue un
|
|---|---|
|
Investigations
AKI
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
anemia/HGB
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Bili
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
confusion
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
constipation
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Creatinine
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
diarrhea
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Dizziness
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
dyspnea
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
fatigue
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
fever
|
8.6%
3/35 • Number of events 3
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Gout/pseuso-gout
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
hypokalemia
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Hypotension
|
8.6%
3/35 • Number of events 3
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
hypoxia
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Infection
|
20.0%
7/35 • Number of events 7
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
mucositits
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
muscle weakness general/M&A/malaise/generalized body aches
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Nausea
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Pain abdomen
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
pain extremity (knee,hip,leg,pelvis,arm,neck,shoulder,wrist,rib,elbow, back, toe)
|
8.6%
3/35 • Number of events 3
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Pleural effusion
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
pre-syncope
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
rotator cuff tear
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
TIA
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Thromboemblic event (pulm embol)/DVT
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
vasovagal
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
vomiting
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
wbc
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Colonic Obstruction
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
Other adverse events
| Measure |
FOLFOX- A
n=35 participants at risk
FOLFOX-A Dose levels -1, 1, 2, 3: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue until level 3 provided that the MTD has not been reached. If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If dose level 1 is not tolerable then dose level -1 will be investigated. Once the MTD is found, the Principal Investigator will determine which dose should be assessed futher and an additional 10 patients will be treated.
FOLFOX-A: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue un
|
|---|---|
|
Investigations
abdominal distention
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Allergic reaction to Oxali and overall allergic reaction
|
11.4%
4/35 • Number of events 4
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
alk phos
|
20.0%
7/35 • Number of events 7
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
alopecia
|
11.4%
4/35 • Number of events 4
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
ALT
|
45.7%
16/35 • Number of events 16
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
ANC
|
31.4%
11/35 • Number of events 11
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
anemia/HGB
|
60.0%
21/35 • Number of events 21
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
anorexia
|
20.0%
7/35 • Number of events 7
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
anxiety
|
8.6%
3/35 • Number of events 3
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
AST
|
48.6%
17/35 • Number of events 17
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
blurry vision
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
BUN
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Calcium/CA
|
14.3%
5/35 • Number of events 5
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Chills/rigors
|
8.6%
3/35 • Number of events 3
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
confusion
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
constipation
|
40.0%
14/35 • Number of events 14
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Cough
|
17.1%
6/35 • Number of events 6
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Creatinine
|
11.4%
4/35 • Number of events 4
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
dehydration
|
8.6%
3/35 • Number of events 3
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Depression
|
8.6%
3/35 • Number of events 3
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
diarrhea
|
42.9%
15/35 • Number of events 15
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Dizziness
|
8.6%
3/35 • Number of events 3
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
dysgeusia (taste)
|
8.6%
3/35 • Number of events 3
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
dysuria
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
dyspnea
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
edema
|
25.7%
9/35 • Number of events 9
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
eye disorder- other
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
fatigue
|
65.7%
23/35 • Number of events 23
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
fever
|
14.3%
5/35 • Number of events 5
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
cramping extermeties
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
flatulanence
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Flushing
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Folliculitis- scalp
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
GERD
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Gout/pseuso-gout
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Headache
|
8.6%
3/35 • Number of events 3
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
hearing impairment
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
heartburn
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
hemorrhoids
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Hiccups
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
hypoalbum
|
11.4%
4/35 • Number of events 4
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
hypokalemia
|
42.9%
15/35 • Number of events 15
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Hypotension
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Infection
|
20.0%
7/35 • Number of events 7
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
insomnia
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
itchiness (head/neck)
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
LDH
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Lymph
|
22.9%
8/35 • Number of events 8
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
mg
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
memory impairment
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
mucositits
|
17.1%
6/35 • Number of events 6
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
muscle weakness general/M&A/malaise/generalized body aches
|
17.1%
6/35 • Number of events 6
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
myositis
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Nausea
|
68.6%
24/35 • Number of events 24
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
neuropathy
|
71.4%
25/35 • Number of events 25
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Phos
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
arthritis
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Pain abdomen
|
17.1%
6/35 • Number of events 6
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Pain bone
|
11.4%
4/35 • Number of events 4
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Pain chest
|
8.6%
3/35 • Number of events 3
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
pain epigastric
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
pain extremity (knee,hip,leg,pelvis,arm,neck,shoulder,wrist,rib,elbow, back, toe)
|
25.7%
9/35 • Number of events 9
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
post nasal drip/nasal congestion
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Renal Calculi(kidney stones)
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
skin laceration (L finger)
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Skin- dry
|
5.7%
2/35 • Number of events 2
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
sodium/NA
|
42.9%
15/35 • Number of events 15
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
spasticity throat
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
thrombocytopenia
|
51.4%
18/35 • Number of events 18
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
Thromboemblic event (pulm embol)/DVT
|
11.4%
4/35 • Number of events 4
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
voice alteration(hoarsness)
|
2.9%
1/35 • Number of events 1
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
vomiting
|
14.3%
5/35 • Number of events 5
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
wbc
|
37.1%
13/35 • Number of events 13
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
|
Investigations
weight loss
|
42.9%
15/35 • Number of events 15
Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place