Trial Outcomes & Findings for Proton w/FOLFIRINOX-Losartan for Pancreatic Cancer (NCT NCT01821729)
NCT ID: NCT01821729
Last Updated: 2020-09-25
Results Overview
The number of participants that received treatment with proton radiation along with FOLFIRINOX-Losartan and then subsequently underwent attempted surgery and achieved R0 resection. R0 resection means that no cancer cells were seen microscopically at the resection margin.
Recruitment status
UNKNOWN
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
At the time of surgery (approximately 4 months after the start of treatment)
Results posted on
2020-09-25
Participant Flow
Participant milestones
| Measure |
Experimental Arm
FOLFIRINOX, Losartan, Proton Beam Radiation Therapy
FOLFIRINOX: Oxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes
Losartan: Taken orally every day during Phase I for all 8 cycles
Proton Beam Radiation: 30-45 minutes per day, daily Monday-Friday
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
Received Chemoradiotherapy
|
45
|
|
Overall Study
Underwent Attempted Surgery
|
42
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Experimental Arm
FOLFIRINOX, Losartan, Proton Beam Radiation Therapy
FOLFIRINOX: Oxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes
Losartan: Taken orally every day during Phase I for all 8 cycles
Proton Beam Radiation: 30-45 minutes per day, daily Monday-Friday
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=49 Participants
FOLFIRINOX, Losartan, Proton Beam Radiation Therapy
FOLFIRINOX: Oxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes
Losartan: Taken orally every day during Phase I for all 8 cycles
Proton Beam Radiation: 30-45 minutes per day, daily Monday-Friday
|
|---|---|
|
Age, Continuous
|
63 years
n=49 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=49 Participants
|
|
Region of Enrollment
United States
|
49 Participants
n=49 Participants
|
|
ECOG PS
0
|
36 Participants
n=49 Participants
|
|
ECOG PS
1
|
13 Participants
n=49 Participants
|
|
CA19-9 level
<35 U/mL (Normal)
|
9 Participants
n=49 Participants
|
|
CA19-9 level
≥ 35 U/mL (Elevated)
|
40 Participants
n=49 Participants
|
|
CEA level
<3.4 ng/mL (Normal)
|
30 Participants
n=48 Participants • CEA levels were not available for one participant
|
|
CEA level
≥3.4 ng/mL (Elevated)
|
18 Participants
n=48 Participants • CEA levels were not available for one participant
|
|
Tumor site
Head
|
31 Participants
n=49 Participants
|
|
Tumor site
Body
|
14 Participants
n=49 Participants
|
|
Tumor site
Tail
|
4 Participants
n=49 Participants
|
|
Tumor size
|
41 mm
n=49 Participants
|
|
Vascular involvement
Arterial alone
|
15 Participants
n=47 Participants • Two participants did not have vascular involvement
|
|
Vascular involvement
Venous alone
|
11 Participants
n=47 Participants • Two participants did not have vascular involvement
|
|
Vascular involvement
Arterial + venous
|
21 Participants
n=47 Participants • Two participants did not have vascular involvement
|
PRIMARY outcome
Timeframe: At the time of surgery (approximately 4 months after the start of treatment)The number of participants that received treatment with proton radiation along with FOLFIRINOX-Losartan and then subsequently underwent attempted surgery and achieved R0 resection. R0 resection means that no cancer cells were seen microscopically at the resection margin.
Outcome measures
| Measure |
Experimental Arm
n=49 Participants
FOLFIRINOX, Losartan, Proton Beam Radiation Therapy
FOLFIRINOX: Oxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes
Losartan: Taken orally every day during Phase I for all 8 cycles
Proton Beam Radiation: 30-45 minutes per day, daily Monday-Friday
|
|---|---|
|
Number of Participants With R0 Resection
|
34 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment until death or progression, median duration of 17.5 monthsTo determine the progression free survival of patients with locally advanced disease who receive FOLFIRINOX-Losartan and proton beam radiation therapy. Disease progression was assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Progressive disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesion, taking as reference the smal lest sum LD recorded since the treatment started or the appearance of one or more new lesions (new lesions must be \> slice thickness).
Outcome measures
| Measure |
Experimental Arm
n=49 Participants
FOLFIRINOX, Losartan, Proton Beam Radiation Therapy
FOLFIRINOX: Oxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes
Losartan: Taken orally every day during Phase I for all 8 cycles
Proton Beam Radiation: 30-45 minutes per day, daily Monday-Friday
|
|---|---|
|
Progression-Free Survival
|
17.5 Months
Interval 13.9 to 22.7
|
SECONDARY outcome
Timeframe: 2 yearsTo determine overall survival in patients treated with preoperative FOLFIRINOX and proton beam radiation therapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsTo determine the overall survival of patients with locally advanced disease who receive FOLFIRINOX-Losartan without proton radiation (i.e. patients who demonstrate progression at restaging)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsTo determine the toxicity of FOLFIRINOX-Losartan in patients with locally advanced pancreatic disease
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsTo determine the toxicity of FOLFIRINOX-Losartan and proton beam radiation in patients with locally advanced pancreatic cancer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsTo determine the rate of downstaging to surgical resection of FOLFIRINOX-Losartan followed by proton radiation in patients with locally advanced pancreatic cancer
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsTo determine the correlation between a panel of somatic genetic mutations (SNaPSHOT) and outcome in locally advanced pancreatic cancer treated with FOLFIRINOX-Losartan +/- proton beam radiation/capecitabine
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsTo determine the correlation between circulating biomarkers of TGF-B1 downregulation, including circulating Collagen I levels, and outcome in locally advanced pancreatic cancer treated with FOLFIRINOX-Losartan +/- proton beam radiation/capecitabine.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsDescribe quality of life, symptom burden and mood in the study population
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsTo measure utilization of health services (ER, hospital and ICU visits) in the study population
Outcome measures
Outcome data not reported
Adverse Events
Experimental Arm
Serious events: 15 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental Arm
n=49 participants at risk
FOLFIRINOX, Losartan, Proton Beam Radiation Therapy
FOLFIRINOX: Oxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes
Losartan: Taken orally every day during Phase I for all 8 cycles
Proton Beam Radiation: 30-45 minutes per day, daily Monday-Friday
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.1%
2/49 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/49 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
General disorders
Fatigue
|
4.1%
2/49 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.0%
1/49 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
4.1%
2/49 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/49 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
10.2%
5/49 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
2.0%
1/49 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Nausea
|
6.1%
3/49 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
2/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Investigations
Alanine aminotransferase increased
|
4.1%
2/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/49 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Investigations
Neutrophil count decreased
|
10.2%
5/49 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Investigations
Platelet count decreased
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Investigations
Weight loss
|
2.0%
1/49 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Investigations
White blood cell decreased
|
2.0%
1/49 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.1%
2/49 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Nervous system disorders
Ataxia
|
2.0%
1/49 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
Other adverse events
| Measure |
Experimental Arm
n=49 participants at risk
FOLFIRINOX, Losartan, Proton Beam Radiation Therapy
FOLFIRINOX: Oxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes
Losartan: Taken orally every day during Phase I for all 8 cycles
Proton Beam Radiation: 30-45 minutes per day, daily Monday-Friday
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.2%
5/49 • Number of events 11 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
12.2%
6/49 • Number of events 8 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
General disorders
Chills
|
12.2%
6/49 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
General disorders
Edema limbs
|
20.4%
10/49 • Number of events 13 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
General disorders
Fatigue
|
81.6%
40/49 • Number of events 124 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
General disorders
Fever
|
20.4%
10/49 • Number of events 13 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
General disorders
Localized edema
|
12.2%
6/49 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
General disorders
Malaise
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
General disorders
Non-cardiac chest pain
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.4%
10/49 • Number of events 14 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.1%
3/49 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
7/49 • Number of events 11 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
26.5%
13/49 • Number of events 27 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
18.4%
9/49 • Number of events 13 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
75.5%
37/49 • Number of events 105 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Bloating
|
26.5%
13/49 • Number of events 16 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Colitis
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Constipation
|
65.3%
32/49 • Number of events 72 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
59.2%
29/49 • Number of events 101 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
10.2%
5/49 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
18.4%
9/49 • Number of events 13 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
7/49 • Number of events 9 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Flatulence
|
26.5%
13/49 • Number of events 20 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Gastritis
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
6.1%
3/49 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Malabsorption
|
22.4%
11/49 • Number of events 11 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
24.5%
12/49 • Number of events 15 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Nausea
|
67.3%
33/49 • Number of events 123 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Oral pain
|
8.2%
4/49 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Vomiting
|
44.9%
22/49 • Number of events 53 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
26.5%
13/49 • Number of events 23 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Immune system disorders
Allergic reaction
|
10.2%
5/49 • Number of events 10 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Infections and infestations
Upper respiratory infection
|
6.1%
3/49 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Infections and infestations
Urinary tract infection
|
8.2%
4/49 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
8.2%
4/49 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Investigations
Alanine aminotransferase increased
|
20.4%
10/49 • Number of events 14 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
10.2%
5/49 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Investigations
Blood bilirubin increased
|
18.4%
9/49 • Number of events 14 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Investigations
Neutrophil count decreased
|
12.2%
6/49 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Investigations
Platelet count decreased
|
26.5%
13/49 • Number of events 16 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Investigations
Weight loss
|
67.3%
33/49 • Number of events 91 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
73.5%
36/49 • Number of events 80 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
44.9%
22/49 • Number of events 59 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.4%
11/49 • Number of events 21 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.2%
4/49 • Number of events 5 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
3/49 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
38.8%
19/49 • Number of events 33 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.2%
6/49 • Number of events 8 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.2%
5/49 • Number of events 5 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
4/49 • Number of events 8 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder -
|
18.4%
9/49 • Number of events 20 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Nervous system disorders
Concentration impairment
|
8.2%
4/49 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Nervous system disorders
Dizziness
|
44.9%
22/49 • Number of events 37 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Nervous system disorders
Dysarthria
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Nervous system disorders
Dysgeusia
|
36.7%
18/49 • Number of events 24 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Nervous system disorders
Paresthesia
|
8.2%
4/49 • Number of events 5 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
71.4%
35/49 • Number of events 131 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Nervous system disorders
Spasticity
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Nervous system disorders
Tremor
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
18.4%
9/49 • Number of events 14 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Psychiatric disorders
Anxiety
|
44.9%
22/49 • Number of events 31 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Psychiatric disorders
Depression
|
14.3%
7/49 • Number of events 8 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Psychiatric disorders
Insomnia
|
40.8%
20/49 • Number of events 36 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
6/49 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.5%
12/49 • Number of events 15 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.3%
8/49 • Number of events 11 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
14.3%
7/49 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.2%
4/49 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.2%
6/49 • Number of events 8 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
24.5%
12/49 • Number of events 24 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Renal and urinary disorders
Hematuria
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
12.2%
6/49 • Number of events 8 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Renal and urinary disorders
Urine discoloration
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Vascular disorders
Hypertension
|
6.1%
3/49 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Vascular disorders
Hypotension
|
32.7%
16/49 • Number of events 28 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Vascular disorders
Thromboembolic event
|
10.2%
5/49 • Number of events 5 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
12.2%
6/49 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to approximately 2 years
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place