Trial Outcomes & Findings for PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations (NCT NCT01074970)
NCT ID: NCT01074970
Last Updated: 2024-09-19
Results Overview
To evaluate 2-year disease-free survival (DFS), in patients with confirmed TNBC or ER/PR + HER2-, known BRCA1/2 mutations treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
135 participants
Primary outcome timeframe
24 months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Safety Cohort 1: Rucaparib 24 mg With Cisplatin
Cisplatin: 75 mg/m\^2 of Cisplatin will be administered via IV infusion over 60 minutes on day 1 of every 21 days for 4 cycles.
Rucaparib: 24 mg of Rucaparib will be administered on day 1-3 of every 21 days for cycle 2-4 via IV infusion followed in one hour by Cisplatin.
|
Safety Cohort 2: Rucaparib 30 mg With Cisplatin
Cisplatin: 75 mg/m\^2 of Cisplatin will be administered via IV infusion over 60 minutes on day 1 of every 21 days for 4 cycles.
Rucaparib: 30 mg of Rucaparib will be administered on day 1-3 of every 21 days for cycle 2-4 via IV infusion followed in one hour by Cisplatin.
|
Arm A: Cisplatin Monotherapy
Cisplatin: 75 mg/m\^2 of Cisplatin will be administered via IV infusion over 60 minutes on day 1 of every 21 days for 4 cycles.
|
Arm B: Combination Therapy
Cisplatin: 75 mg/m\^2 of Cisplatin will be administered via IV infusion over 60 minutes on day 1 of every 21 days for 4 cycles.
Rucaparib: Rucaparib dose should be increased to 30 mg day 1-3 of every 21 days for cycles 2-4 in the absence of dose limiting toxicity in cycle 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
65
|
57
|
|
Overall Study
COMPLETED
|
3
|
5
|
44
|
40
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
21
|
17
|
Reasons for withdrawal
| Measure |
Safety Cohort 1: Rucaparib 24 mg With Cisplatin
Cisplatin: 75 mg/m\^2 of Cisplatin will be administered via IV infusion over 60 minutes on day 1 of every 21 days for 4 cycles.
Rucaparib: 24 mg of Rucaparib will be administered on day 1-3 of every 21 days for cycle 2-4 via IV infusion followed in one hour by Cisplatin.
|
Safety Cohort 2: Rucaparib 30 mg With Cisplatin
Cisplatin: 75 mg/m\^2 of Cisplatin will be administered via IV infusion over 60 minutes on day 1 of every 21 days for 4 cycles.
Rucaparib: 30 mg of Rucaparib will be administered on day 1-3 of every 21 days for cycle 2-4 via IV infusion followed in one hour by Cisplatin.
|
Arm A: Cisplatin Monotherapy
Cisplatin: 75 mg/m\^2 of Cisplatin will be administered via IV infusion over 60 minutes on day 1 of every 21 days for 4 cycles.
|
Arm B: Combination Therapy
Cisplatin: 75 mg/m\^2 of Cisplatin will be administered via IV infusion over 60 minutes on day 1 of every 21 days for 4 cycles.
Rucaparib: Rucaparib dose should be increased to 30 mg day 1-3 of every 21 days for cycles 2-4 in the absence of dose limiting toxicity in cycle 1.
|
|---|---|---|---|---|
|
Overall Study
Never Treated
|
0
|
0
|
8
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
4
|
3
|
|
Overall Study
Disease progression during treatment
|
3
|
1
|
2
|
9
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
6
|
4
|
Baseline Characteristics
PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations
Baseline characteristics by cohort
| Measure |
Arm A: Cisplatin Monotherapy
n=65 Participants
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
|
Arm B: Combination Therapy
n=57 Participants
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
|
Safety Cohort 1: Rucaparib 24 mg With Cisplatin
n=7 Participants
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
Rucaparib 16mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
|
Safety Cohort 2: Rucaparib 30 mg With Cisplatin
n=6 Participants
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
47 years
n=7 Participants
|
46 years
n=5 Participants
|
49 years
n=4 Participants
|
47 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
135 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
57 participants
n=7 Participants
|
7 participants
n=5 Participants
|
6 participants
n=4 Participants
|
135 participants
n=21 Participants
|
|
ECOG Performance Score
ECOG PS 0
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
|
ECOG Performance Score
ECOG PS 1
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
ECOG Performance Score
Not Collected or Available
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
BRCA2 Status Known at Entry
Yes
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
BRCA2 Status Known at Entry
No
|
63 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
131 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 monthsTo evaluate 2-year disease-free survival (DFS), in patients with confirmed TNBC or ER/PR + HER2-, known BRCA1/2 mutations treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy
Outcome measures
| Measure |
Arm A: Cisplatin Monotherapy
n=65 Participants
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
Cisplatin: Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
|
Arm B: Combination Therapy
n=63 Participants
Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
Rucaparib: Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
Cisplatin: Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
|
|---|---|---|
|
Two-year Disease Free Survival
|
54.2 percentage of participants
Interval 39.8 to 66.6
|
64.1 percentage of participants
Interval 50.3 to 75.0
|
SECONDARY outcome
Timeframe: 60 monthsTo evaluate 5-year DFS, in patients with confirmed TNBC or ER/PR + HER2-, known BRCA1/2 mutations treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy
Outcome measures
| Measure |
Arm A: Cisplatin Monotherapy
n=65 Participants
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
Cisplatin: Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
|
Arm B: Combination Therapy
n=63 Participants
Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
Rucaparib: Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
Cisplatin: Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
|
|---|---|---|
|
Five-year Disease Free Survival
|
38.3 percentage of participants
Interval 24.6 to 51.8
|
50.1 percentage of participants
Interval 35.5 to 63.0
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: Data for this secondary objective was not collected or analyzed
To determine 5-year overall survival
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsTo characterize the side effects and tolerability of cisplatin and cisplatin plus Rucaparib in patients with residual disease following preoperative chemotherapy by summarizing Grade 2,3, # 4 toxicities according to CTCAE v3.0
Outcome measures
| Measure |
Arm A: Cisplatin Monotherapy
n=65 Participants
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
Cisplatin: Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
|
Arm B: Combination Therapy
n=63 Participants
Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
Rucaparib: Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
Cisplatin: Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
|
|---|---|---|
|
Summarize Grade 2,3, # 4 Toxicities
Thrombocytopenia Gr 2
|
2 participants
|
0 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Thrombocytopenia Gr 3
|
0 participants
|
2 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Neutropenia Gr 2
|
16 participants
|
13 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Neutropenia Gr 3
|
11 participants
|
16 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Neutropenia Gr 4
|
0 participants
|
1 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Neutropenic fever Gr 2
|
1 participants
|
1 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Anemia Gr 2
|
5 participants
|
7 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Nausea Gr 2
|
13 participants
|
16 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Nausea Gr 3
|
0 participants
|
3 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Anorexia Gr 2
|
3 participants
|
7 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Fatigue Gr 2
|
14 participants
|
11 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Fatigue Gr 3
|
3 participants
|
6 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Fatigue Gr 4
|
1 participants
|
0 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Tinnitus Gr 2
|
16 participants
|
12 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Tinnitus Gr 3
|
1 participants
|
1 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Nephropathy Gr 2
|
1 participants
|
2 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Neuropathy Gr 2
|
1 participants
|
3 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Neuropathy Gr 3
|
0 participants
|
1 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Vomiting Gr 2
|
5 participants
|
7 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Vomiting Gr 3
|
0 participants
|
3 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Hepatic abnormality Gr 3
|
1 participants
|
3 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Hepatic abnormality Gr 4
|
1 participants
|
0 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Rash Gr 2
|
2 participants
|
2 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Headache Gr 2
|
2 participants
|
5 participants
|
|
Summarize Grade 2,3, # 4 Toxicities
Dysguesia Gr 2
|
3 participants
|
1 participants
|
Adverse Events
Arm A : Cisplatin Monotherapy
Serious events: 1 serious events
Other events: 56 other events
Deaths: 26 deaths
Arm B : Combination Therapy
Serious events: 6 serious events
Other events: 61 other events
Deaths: 25 deaths
Safety Cohort 1: Rucaparib 24 mg With Cisplatin
Serious events: 1 serious events
Other events: 7 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Arm A : Cisplatin Monotherapy
n=65 participants at risk
Cisplatin: 75 mg/m\^2 of Cisplatin will be administered via IV infusion over 60 minutes on day 1 of every 21 days for 4 cycles.
|
Arm B : Combination Therapy
n=63 participants at risk
Cisplatin: 75 mg/m\^2 of Cisplatin will be administered via IV infusion over 60 minutes on day 1 of every 21 days for 4 cycles.
Rucaparib: 24 mg of Rucaparib will be administered on day 1-3 of every 21 days for cycle 1 via IV infusion followed in one hour by Cisplatin. Rucaparib dose should be increased to 30 mg day 1-3 of every 21 days for cycles 2-4 in the absence of dose limiting toxicity in cycle 1.
|
Safety Cohort 1: Rucaparib 24 mg With Cisplatin
n=7 participants at risk
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles Rucaparib 16mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
|
|---|---|---|---|
|
General disorders
SECONDARY MALIGNANCY - POSSIBLY RELATED TO CANCER TREATMENT (SPECIFY, __)
|
1.5%
1/65 • Number of events 1 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Psychiatric disorders
MOOD ALTERATION
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/65 • 12 months
|
3.2%
2/63 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
PAIN
|
0.00%
0/65 • 12 months
|
3.2%
2/63 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
0.00%
0/65 • 12 months
|
0.00%
0/63 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Arm A : Cisplatin Monotherapy
n=65 participants at risk
Cisplatin: 75 mg/m\^2 of Cisplatin will be administered via IV infusion over 60 minutes on day 1 of every 21 days for 4 cycles.
|
Arm B : Combination Therapy
n=63 participants at risk
Cisplatin: 75 mg/m\^2 of Cisplatin will be administered via IV infusion over 60 minutes on day 1 of every 21 days for 4 cycles.
Rucaparib: 24 mg of Rucaparib will be administered on day 1-3 of every 21 days for cycle 1 via IV infusion followed in one hour by Cisplatin. Rucaparib dose should be increased to 30 mg day 1-3 of every 21 days for cycles 2-4 in the absence of dose limiting toxicity in cycle 1.
|
Safety Cohort 1: Rucaparib 24 mg With Cisplatin
n=7 participants at risk
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles Rucaparib 16mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
|
|---|---|---|---|
|
Metabolism and nutrition disorders
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
1.5%
1/65 • Number of events 1 • 12 months
|
6.3%
4/63 • Number of events 10 • 12 months
|
0.00%
0/7 • 12 months
|
|
Investigations
ALKALINE PHOSPHATASE
|
7.7%
5/65 • Number of events 5 • 12 months
|
9.5%
6/63 • Number of events 9 • 12 months
|
0.00%
0/7 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
1.5%
1/65 • Number of events 1 • 12 months
|
3.2%
2/63 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY
|
1.5%
1/65 • Number of events 1 • 12 months
|
4.8%
3/63 • Number of events 3 • 12 months
|
0.00%
0/7 • 12 months
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
3.1%
2/65 • Number of events 4 • 12 months
|
7.9%
5/63 • Number of events 7 • 12 months
|
0.00%
0/7 • 12 months
|
|
Metabolism and nutrition disorders
ANOREXIA
|
21.5%
14/65 • Number of events 17 • 12 months
|
19.0%
12/63 • Number of events 26 • 12 months
|
71.4%
5/7 • Number of events 20 • 12 months
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
3.1%
2/65 • Number of events 5 • 12 months
|
9.5%
6/63 • Number of events 7 • 12 months
|
0.00%
0/7 • 12 months
|
|
Ear and labyrinth disorders
AUDITORY/EAR
|
1.5%
1/65 • Number of events 1 • 12 months
|
9.5%
6/63 • Number of events 6 • 12 months
|
0.00%
0/7 • 12 months
|
|
Investigations
BILIRUBIN (HYPERBILIRUBINEMIA)
|
1.5%
1/65 • Number of events 1 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Metabolism and nutrition disorders
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
|
1.5%
1/65 • Number of events 1 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
Metabolism and nutrition disorders
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
1.5%
1/65 • Number of events 1 • 12 months
|
3.2%
2/63 • Number of events 4 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
30.8%
20/65 • Number of events 27 • 12 months
|
44.4%
28/63 • Number of events 40 • 12 months
|
57.1%
4/7 • Number of events 8 • 12 months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS
|
7.7%
5/65 • Number of events 5 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
12.3%
8/65 • Number of events 10 • 12 months
|
12.7%
8/63 • Number of events 8 • 12 months
|
71.4%
5/7 • Number of events 5 • 12 months
|
|
Investigations
CREATININE
|
3.1%
2/65 • Number of events 2 • 12 months
|
6.3%
4/63 • Number of events 11 • 12 months
|
0.00%
0/7 • 12 months
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.5%
1/65 • Number of events 1 • 12 months
|
12.7%
8/63 • Number of events 14 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
DENTAL: TEETH
|
1.5%
1/65 • Number of events 1 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
Vascular disorders
DERMAL CHANGE LYMPHEDEMA, PHLEBOLYMPHEDEMA
|
1.5%
1/65 • Number of events 1 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN
|
1.5%
1/65 • Number of events 1 • 12 months
|
7.9%
5/63 • Number of events 6 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
DIARRHEA
|
6.2%
4/65 • Number of events 8 • 12 months
|
15.9%
10/63 • Number of events 13 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Nervous system disorders
DIZZINESS
|
4.6%
3/65 • Number of events 3 • 12 months
|
15.9%
10/63 • Number of events 12 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
1.5%
1/65 • Number of events 1 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
10.8%
7/65 • Number of events 8 • 12 months
|
11.1%
7/63 • Number of events 8 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
General disorders
EDEMA: LIMB
|
12.3%
8/65 • Number of events 9 • 12 months
|
20.6%
13/63 • Number of events 15 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
50.8%
33/65 • Number of events 56 • 12 months
|
58.7%
37/63 • Number of events 137 • 12 months
|
71.4%
5/7 • Number of events 21 • 12 months
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
3.1%
2/65 • Number of events 2 • 12 months
|
4.8%
3/63 • Number of events 3 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
General disorders
FLU-LIKE SYNDROME
|
1.5%
1/65 • Number of events 1 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Metabolism and nutrition disorders
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
10.8%
7/65 • Number of events 15 • 12 months
|
14.3%
9/63 • Number of events 18 • 12 months
|
0.00%
0/7 • 12 months
|
|
Metabolism and nutrition disorders
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
|
1.5%
1/65 • Number of events 1 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
1.5%
1/65 • Number of events 1 • 12 months
|
7.9%
5/63 • Number of events 5 • 12 months
|
42.9%
3/7 • Number of events 3 • 12 months
|
|
Ear and labyrinth disorders
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
|
3.1%
2/65 • Number of events 2 • 12 months
|
3.2%
2/63 • Number of events 2 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
9.2%
6/65 • Number of events 6 • 12 months
|
12.7%
8/63 • Number of events 9 • 12 months
|
42.9%
3/7 • Number of events 6 • 12 months
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
26.2%
17/65 • Number of events 21 • 12 months
|
33.3%
21/63 • Number of events 32 • 12 months
|
14.3%
1/7 • Number of events 5 • 12 months
|
|
Blood and lymphatic system disorders
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
|
1.5%
1/65 • Number of events 1 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
Vascular disorders
HOT FLASHES/FLUSHES
|
4.6%
3/65 • Number of events 3 • 12 months
|
6.3%
4/63 • Number of events 9 • 12 months
|
14.3%
1/7 • Number of events 2 • 12 months
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION
|
1.5%
1/65 • Number of events 1 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Vascular disorders
HYPERTENSION
|
3.1%
2/65 • Number of events 2 • 12 months
|
6.3%
4/63 • Number of events 4 • 12 months
|
0.00%
0/7 • 12 months
|
|
Vascular disorders
HYPOTENSION
|
1.5%
1/65 • Number of events 1 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Infections and infestations
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY)
|
1.5%
1/65 • Number of events 1 • 12 months
|
3.2%
2/63 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
1.5%
1/65 • Number of events 1 • 12 months
|
7.9%
5/63 • Number of events 5 • 12 months
|
28.6%
2/7 • Number of events 3 • 12 months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS
|
12.3%
8/65 • Number of events 9 • 12 months
|
11.1%
7/63 • Number of events 8 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC
|
3.1%
2/65 • Number of events 2 • 12 months
|
4.8%
3/63 • Number of events 3 • 12 months
|
0.00%
0/7 • 12 months
|
|
Psychiatric disorders
INSOMNIA
|
7.7%
5/65 • Number of events 5 • 12 months
|
20.6%
13/63 • Number of events 15 • 12 months
|
57.1%
4/7 • Number of events 9 • 12 months
|
|
Investigations
LEUKOCYTES (TOTAL WBC)
|
20.0%
13/65 • Number of events 28 • 12 months
|
27.0%
17/63 • Number of events 53 • 12 months
|
0.00%
0/7 • 12 months
|
|
Blood and lymphatic system disorders
LYMPHATICS
|
1.5%
1/65 • Number of events 1 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
Musculoskeletal and connective tissue disorders
LYMPHEDEMA-RELATED FIBROSIS
|
1.5%
1/65 • Number of events 1 • 12 months
|
4.8%
3/63 • Number of events 3 • 12 months
|
0.00%
0/7 • 12 months
|
|
Investigations
LYMPHOPENIA
|
10.8%
7/65 • Number of events 14 • 12 months
|
20.6%
13/63 • Number of events 22 • 12 months
|
0.00%
0/7 • 12 months
|
|
Metabolism and nutrition disorders
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
3.1%
2/65 • Number of events 2 • 12 months
|
3.2%
2/63 • Number of events 4 • 12 months
|
0.00%
0/7 • 12 months
|
|
Investigations
METABOLIC/LABORATORY
|
1.5%
1/65 • Number of events 2 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
Psychiatric disorders
MOOD ALTERATION
|
18.5%
12/65 • Number of events 14 • 12 months
|
12.7%
8/63 • Number of events 13 • 12 months
|
42.9%
3/7 • Number of events 7 • 12 months
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (CLINICAL EXAM)
|
7.7%
5/65 • Number of events 5 • 12 months
|
11.1%
7/63 • Number of events 7 • 12 months
|
14.3%
1/7 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC)
|
3.1%
2/65 • Number of events 2 • 12 months
|
6.3%
4/63 • Number of events 6 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY)
|
3.1%
2/65 • Number of events 2 • 12 months
|
6.3%
4/63 • Number of events 5 • 12 months
|
0.00%
0/7 • 12 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
|
1.5%
1/65 • Number of events 1 • 12 months
|
9.5%
6/63 • Number of events 7 • 12 months
|
0.00%
0/7 • 12 months
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
3.1%
2/65 • Number of events 2 • 12 months
|
0.00%
0/63 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CAVITY/PARANASAL SINUS REACTIONS
|
1.5%
1/65 • Number of events 1 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
NAUSEA
|
67.7%
44/65 • Number of events 63 • 12 months
|
71.4%
45/63 • Number of events 90 • 12 months
|
100.0%
7/7 • Number of events 21 • 12 months
|
|
Nervous system disorders
NEUROLOGY
|
1.5%
1/65 • Number of events 1 • 12 months
|
3.2%
2/63 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
16.9%
11/65 • Number of events 13 • 12 months
|
27.0%
17/63 • Number of events 27 • 12 months
|
42.9%
3/7 • Number of events 5 • 12 months
|
|
Investigations
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
50.8%
33/65 • Number of events 69 • 12 months
|
57.1%
36/63 • Number of events 89 • 12 months
|
57.1%
4/7 • Number of events 6 • 12 months
|
|
Eye disorders
OCULAR/VISUAL
|
4.6%
3/65 • Number of events 4 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Ear and labyrinth disorders
OTITIS, MIDDLE EAR (NON-INFECTIOUS)
|
1.5%
1/65 • Number of events 1 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
PAIN
|
43.1%
28/65 • Number of events 47 • 12 months
|
69.8%
44/63 • Number of events 129 • 12 months
|
71.4%
5/7 • Number of events 19 • 12 months
|
|
General disorders
PAIN - OTHER
|
12.3%
8/65 • Number of events 9 • 12 months
|
19.0%
12/63 • Number of events 14 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Cardiac disorders
PALPITATIONS
|
1.5%
1/65 • Number of events 1 • 12 months
|
3.2%
2/63 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
Investigations
PLATELETS
|
6.2%
4/65 • Number of events 6 • 12 months
|
9.5%
6/63 • Number of events 11 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
|
3.1%
2/65 • Number of events 2 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
Metabolism and nutrition disorders
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
4.6%
3/65 • Number of events 3 • 12 months
|
11.1%
7/63 • Number of events 13 • 12 months
|
0.00%
0/7 • 12 months
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
3.1%
2/65 • Number of events 2 • 12 months
|
3.2%
2/63 • Number of events 4 • 12 months
|
0.00%
0/7 • 12 months
|
|
Psychiatric disorders
PSYCHOSIS (HALLUCINATIONS/DELUSIONS)
|
1.5%
1/65 • Number of events 1 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY
|
4.6%
3/65 • Number of events 5 • 12 months
|
4.8%
3/63 • Number of events 4 • 12 months
|
0.00%
0/7 • 12 months
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
3.1%
2/65 • Number of events 2 • 12 months
|
0.00%
0/63 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
1.5%
1/65 • Number of events 1 • 12 months
|
6.3%
4/63 • Number of events 5 • 12 months
|
0.00%
0/7 • 12 months
|
|
Renal and urinary disorders
RENAL/GENITOURINARY
|
1.5%
1/65 • Number of events 1 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
Metabolism and nutrition disorders
SODIUM, SERUM-LOW (HYPONATREMIA)
|
1.5%
1/65 • Number of events 1 • 12 months
|
4.8%
3/63 • Number of events 3 • 12 months
|
0.00%
0/7 • 12 months
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA
|
1.5%
1/65 • Number of events 1 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Skin and subcutaneous tissue disorders
SWEATING (DIAPHORESIS)
|
1.5%
1/65 • Number of events 1 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
Nervous system disorders
TASTE ALTERATION (DYSGEUSIA)
|
10.8%
7/65 • Number of events 11 • 12 months
|
6.3%
4/63 • Number of events 4 • 12 months
|
42.9%
3/7 • Number of events 5 • 12 months
|
|
Ear and labyrinth disorders
TINNITUS
|
26.2%
17/65 • Number of events 23 • 12 months
|
27.0%
17/63 • Number of events 32 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
TRISMUS (DIFFICULTY, RESTRICTION OR PAIN WHEN OPENING MOUTH)
|
1.5%
1/65 • Number of events 1 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
3.1%
2/65 • Number of events 2 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Eye disorders
VISION-BLURRED VISION
|
3.1%
2/65 • Number of events 3 • 12 months
|
4.8%
3/63 • Number of events 3 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
VOMITING
|
15.4%
10/65 • Number of events 12 • 12 months
|
31.7%
20/63 • Number of events 43 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Investigations
WEIGHT GAIN
|
1.5%
1/65 • Number of events 1 • 12 months
|
1.6%
1/63 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
Investigations
WEIGHT LOSS
|
3.1%
2/65 • Number of events 2 • 12 months
|
0.00%
0/63 • 12 months
|
0.00%
0/7 • 12 months
|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW
|
0.00%
0/65 • 12 months
|
4.8%
3/63 • Number of events 4 • 12 months
|
0.00%
0/7 • 12 months
|
|
Injury, poisoning and procedural complications
BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA)
|
0.00%
0/65 • 12 months
|
3.2%
2/63 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
Injury, poisoning and procedural complications
BURN
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINE-RANGE OF MOTION
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Psychiatric disorders
CONFUSION
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
DISTENSION/BLOATING, ABDOMINAL
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Eye disorders
DRY EYE SYNDROME
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
EDEMA: HEAD AND NECK
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
EDEMA: TRUNK/GENITAL
|
0.00%
0/65 • 12 months
|
4.8%
3/63 • Number of events 5 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
EDEMA: VISCERA
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
ENTERITIS (INFLAMMATION OF THE SMALL BOWEL)
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
EXTREMITY-LOWER (GAIT/WALKING)
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Vascular disorders
FLUSHING
|
0.00%
0/65 • 12 months
|
6.3%
4/63 • Number of events 6 • 12 months
|
0.00%
0/7 • 12 months
|
|
Injury, poisoning and procedural complications
FRACTURE
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER (SPECIFY, __)
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
Renal and urinary disorders
GLOMERULAR FILTRATION RATE
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 3 • 12 months
|
0.00%
0/7 • 12 months
|
|
Renal and urinary disorders
HEMORRHAGE, GU
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
HICCOUGHS (HICCUPS, SINGULTUS)
|
0.00%
0/65 • 12 months
|
3.2%
2/63 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
Renal and urinary disorders
INCONTINENCE, URINARY
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
INTRA-OPERATIVE INJURY
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Metabolism and nutrition disorders
MAGNESIUM, SERUM-HIGH (HYPERMAGNESEMIA)
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
NEUROPATHY: CRANIAL
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
0.00%
0/65 • 12 months
|
9.5%
6/63 • Number of events 7 • 12 months
|
0.00%
0/7 • 12 months
|
|
Eye disorders
OPHTHALMOPLEGIA/DIPLOPIA (DOUBLE VISION)
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Vascular disorders
PHLEBOLYMPHATIC CORDING
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
RIGORS/CHILLS
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Infections and infestations
VIRAL HEPATITIS
|
0.00%
0/65 • 12 months
|
1.6%
1/63 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
CHEST PAIN
|
0.00%
0/65 • 12 months
|
0.00%
0/63 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
HEMORRHAGE, GI
|
0.00%
0/65 • 12 months
|
0.00%
0/63 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
JOINT-FUNCTION
|
0.00%
0/65 • 12 months
|
0.00%
0/63 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
0.00%
0/65 • 12 months
|
0.00%
0/63 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Eye disorders
UVEITIS
|
0.00%
0/65 • 12 months
|
0.00%
0/63 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
Additional Information
Director of Clinical Data Management
Hoosier Cancer Research Network
Phone: 317-634-5842
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place