Trial Outcomes & Findings for Reolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Metastatic Colorectal Cancer (NCT NCT01622543)
NCT ID: NCT01622543
Last Updated: 2023-08-23
Results Overview
Time from the day of randomization until the first observation of objective disease relapse or progression, or the appearance of new lesions or death due to any cause. If a patient had not relapsed/progressed or died, PFS was censored on the date of last disease assessment defined as the earliest test date of target lesion or non-target lesions (if patient had no target lesions). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
19 months
Results posted on
2023-08-23
Participant Flow
6 patients were enrolled in a safety run-in phase of the study before randomized component was started. These 6 patients were not included in the final analysis.
Participant milestones
| Measure |
Folfox Plus Bevacizumab and Reolysin
Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab infusion on day 1 of a 14 day cycle (IV bevacizumab 5mg/kg over 1 hour, oxaliplatin 85mg/m\^2 and leucovorin 400 mg/m\^2 concurrently over 2 hours, bolus fluorouracil 400 mg/m\^2 after leucovorin, and continuous infusion of fluorouracil 2400 mg/m\^2 over 46 hours) and reolysin 3x10\^10 TCID\_50 over 1 hour on days 1-5 of cycle 2, 4, 6, 8 and alternate cycles thereafter.
|
Folfox Plus Bevacizumab
Folfox plus Bevacizumab: FOLFOX6/bevacizumab infusion on day 1 of a 14 day cycle (IV bevacizumab 5mg/kg over 1 hour, oxaliplatin 85mg/m\^2 and leucovorin 400 mg/m\^2 concurrently over 2 hours, bolus fluorouracil 400 mg/m\^2 after leucovorin, and continuous infusion of fluorouracil 2400 mg/m\^2 over 46 hours).
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
52
|
|
Overall Study
COMPLETED
|
51
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Folfox Plus Bevacizumab and Reolysin
n=51 Participants
Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
|
Folfox Plus Bevacizumab
n=52 Participants
Folfox plus Bevacizumab: FOLFOX6/bevacizumab given every 14 days.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
59 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
51 participants
n=5 Participants
|
52 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
ECOG Performance Status
0
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
ECOG Performance Status
2
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 19 monthsPopulation: All patients randomized
Time from the day of randomization until the first observation of objective disease relapse or progression, or the appearance of new lesions or death due to any cause. If a patient had not relapsed/progressed or died, PFS was censored on the date of last disease assessment defined as the earliest test date of target lesion or non-target lesions (if patient had no target lesions). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Folfox Plus Bevacizumab and Reolysin
n=51 Participants
Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
|
Folfox Plus Bevacizumab
n=52 Participants
Folfox plus Bevacizumab: FOLFOX6/bevacizumab given every 14 days.
|
|---|---|---|
|
Progression Free Survival
|
7.33 Months
Interval 5.42 to 9.17
|
9.13 Months
Interval 7.39 to 11.83
|
SECONDARY outcome
Timeframe: Baseline and at 28 weeksPopulation: All patients who had CEA levels measures at baseline and week 28.
Changes in CEA level from baseline to week 28 during treatment.
Outcome measures
| Measure |
Folfox Plus Bevacizumab and Reolysin
n=18 Participants
Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
|
Folfox Plus Bevacizumab
n=20 Participants
Folfox plus Bevacizumab: FOLFOX6/bevacizumab given every 14 days.
|
|---|---|---|
|
Changes in CEA Levels
|
-14209.4 ng/mL
Standard Deviation 58829.51
|
-1107.99 ng/mL
Standard Deviation 2670.55
|
SECONDARY outcome
Timeframe: 19 monthsPopulation: All patients randomized to this study
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate =Proportion of (CR + PR) observed over all randomized patients.
Outcome measures
| Measure |
Folfox Plus Bevacizumab and Reolysin
n=51 Participants
Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
|
Folfox Plus Bevacizumab
n=52 Participants
Folfox plus Bevacizumab: FOLFOX6/bevacizumab given every 14 days.
|
|---|---|---|
|
Objective Response Rate
|
27 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: From date of randomization to death from any cause or censored at the time of last known alive, assessed up to 49 monthsPopulation: All randomized patients
Time from randomization to death from any cause or censored at the time of last known alive
Outcome measures
| Measure |
Folfox Plus Bevacizumab and Reolysin
n=51 Participants
Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
|
Folfox Plus Bevacizumab
n=52 Participants
Folfox plus Bevacizumab: FOLFOX6/bevacizumab given every 14 days.
|
|---|---|---|
|
Overall Survival
|
19.3 Months
Interval 14.4 to 23.3
|
20.0 Months
Interval 14.5 to 26.0
|
Adverse Events
Folfox Plus Bevacizumab and Reolysin
Serious events: 22 serious events
Other events: 51 other events
Deaths: 39 deaths
Folfox Plus Bevacizumab
Serious events: 18 serious events
Other events: 52 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Folfox Plus Bevacizumab and Reolysin
n=51 participants at risk
Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
|
Folfox Plus Bevacizumab
n=52 participants at risk
Folfox plus Bevacizumab: FOLFOX6/bevacizumab given every 14 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.9%
3/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Cardiac disorders
Acute coronary syndrome
|
2.0%
1/51 • A median follow-up of 33.5 months
|
3.8%
2/52 • A median follow-up of 33.5 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Cardiac disorders
Heart failure
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/51 • A median follow-up of 33.5 months
|
3.8%
2/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Colonic perforation
|
3.9%
2/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
0.00%
0/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.00%
0/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.9%
2/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • A median follow-up of 33.5 months
|
3.8%
2/52 • A median follow-up of 33.5 months
|
|
General disorders
Fatigue
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Appendicitis perforated
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Enterocolitis infectious
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Lung infection
|
7.8%
4/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Other infections and infestations
|
0.00%
0/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Sepsis
|
5.9%
3/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Injury, poisoning and procedural complications
Prolapse of intestinal stoma
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other neoplasms benign, malignant and unspecified
|
2.0%
1/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.0%
1/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Stroke
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Transient ischemic attacks
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Renal and urinary disorders
Acute kidney injury
|
3.9%
2/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Renal and urinary disorders
Urinary tract pain
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Vascular disorders
Hematoma
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Vascular disorders
Hypertension
|
3.9%
2/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Vascular disorders
Hypotension
|
2.0%
1/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Vascular disorders
Thromboembolic event
|
3.9%
2/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
Other adverse events
| Measure |
Folfox Plus Bevacizumab and Reolysin
n=51 participants at risk
Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
|
Folfox Plus Bevacizumab
n=52 participants at risk
Folfox plus Bevacizumab: FOLFOX6/bevacizumab given every 14 days.
|
|---|---|---|
|
Infections and infestations
Upper respiratory infection
|
15.7%
8/51 • A median follow-up of 33.5 months
|
23.1%
12/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Urinary tract infection
|
7.8%
4/51 • A median follow-up of 33.5 months
|
3.8%
2/52 • A median follow-up of 33.5 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.8%
4/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
Cardiac disorders
Sinus tachycardia
|
3.9%
2/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
Eye disorders
Blurred vision
|
7.8%
4/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
Eye disorders
Dry eye
|
7.8%
4/51 • A median follow-up of 33.5 months
|
3.8%
2/52 • A median follow-up of 33.5 months
|
|
Eye disorders
Watering eyes
|
5.9%
3/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
52.9%
27/51 • A median follow-up of 33.5 months
|
67.3%
35/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Bloating
|
3.9%
2/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Colonic perforation
|
3.9%
2/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Constipation
|
72.5%
37/51 • A median follow-up of 33.5 months
|
61.5%
32/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Diarrhea
|
68.6%
35/51 • A median follow-up of 33.5 months
|
69.2%
36/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Dry mouth
|
11.8%
6/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Dyspepsia
|
19.6%
10/51 • A median follow-up of 33.5 months
|
23.1%
12/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Flatulence
|
13.7%
7/51 • A median follow-up of 33.5 months
|
17.3%
9/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.8%
4/51 • A median follow-up of 33.5 months
|
15.4%
8/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
15.7%
8/51 • A median follow-up of 33.5 months
|
3.8%
2/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Mucositis oral
|
52.9%
27/51 • A median follow-up of 33.5 months
|
59.6%
31/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Nausea
|
70.6%
36/51 • A median follow-up of 33.5 months
|
65.4%
34/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.0%
1/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Oral pain
|
7.8%
4/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
3.9%
2/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
17.6%
9/51 • A median follow-up of 33.5 months
|
15.4%
8/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Rectal pain
|
9.8%
5/51 • A median follow-up of 33.5 months
|
13.5%
7/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.9%
3/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Toothache
|
9.8%
5/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Gastrointestinal disorders
Vomiting
|
47.1%
24/51 • A median follow-up of 33.5 months
|
42.3%
22/52 • A median follow-up of 33.5 months
|
|
General disorders
Chills
|
47.1%
24/51 • A median follow-up of 33.5 months
|
21.2%
11/52 • A median follow-up of 33.5 months
|
|
General disorders
Edema face
|
5.9%
3/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
General disorders
Edema limbs
|
35.3%
18/51 • A median follow-up of 33.5 months
|
19.2%
10/52 • A median follow-up of 33.5 months
|
|
General disorders
Fatigue
|
88.2%
45/51 • A median follow-up of 33.5 months
|
98.1%
51/52 • A median follow-up of 33.5 months
|
|
General disorders
Fever
|
60.8%
31/51 • A median follow-up of 33.5 months
|
28.8%
15/52 • A median follow-up of 33.5 months
|
|
General disorders
Flu like symptoms
|
7.8%
4/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
General disorders
Infusion related reaction
|
3.9%
2/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
General disorders
Malaise
|
3.9%
2/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
General disorders
Non-cardiac chest pain
|
13.7%
7/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
General disorders
Pain
|
11.8%
6/51 • A median follow-up of 33.5 months
|
17.3%
9/52 • A median follow-up of 33.5 months
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Gum infection
|
0.00%
0/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Lung infection
|
11.8%
6/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Other infections and infestations
|
0.00%
0/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Sepsis
|
7.8%
4/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Sinusitis
|
5.9%
3/51 • A median follow-up of 33.5 months
|
3.8%
2/52 • A median follow-up of 33.5 months
|
|
Infections and infestations
Skin infection
|
3.9%
2/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
Injury, poisoning and procedural complications
Bruising
|
5.9%
3/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
Metabolism and nutrition disorders
Anorexia
|
74.5%
38/51 • A median follow-up of 33.5 months
|
69.2%
36/52 • A median follow-up of 33.5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
9.8%
5/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.9%
2/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.9%
3/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.9%
2/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
5/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.7%
7/51 • A median follow-up of 33.5 months
|
34.6%
18/52 • A median follow-up of 33.5 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.8%
4/51 • A median follow-up of 33.5 months
|
3.8%
2/52 • A median follow-up of 33.5 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.9%
2/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
13.7%
7/51 • A median follow-up of 33.5 months
|
13.5%
7/52 • A median follow-up of 33.5 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.5%
12/51 • A median follow-up of 33.5 months
|
13.5%
7/52 • A median follow-up of 33.5 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.8%
5/51 • A median follow-up of 33.5 months
|
13.5%
7/52 • A median follow-up of 33.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
29.4%
15/51 • A median follow-up of 33.5 months
|
28.8%
15/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Dizziness
|
11.8%
6/51 • A median follow-up of 33.5 months
|
11.5%
6/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Dysesthesia
|
9.8%
5/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Dysgeusia
|
29.4%
15/51 • A median follow-up of 33.5 months
|
40.4%
21/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Headache
|
45.1%
23/51 • A median follow-up of 33.5 months
|
46.2%
24/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Memory impairment
|
9.8%
5/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Paresthesia
|
9.8%
5/51 • A median follow-up of 33.5 months
|
13.5%
7/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
88.2%
45/51 • A median follow-up of 33.5 months
|
90.4%
47/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Syncope
|
5.9%
3/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Nervous system disorders
Tremor
|
7.8%
4/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Psychiatric disorders
Anxiety
|
11.8%
6/51 • A median follow-up of 33.5 months
|
23.1%
12/52 • A median follow-up of 33.5 months
|
|
Psychiatric disorders
Depression
|
5.9%
3/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
Psychiatric disorders
Insomnia
|
37.3%
19/51 • A median follow-up of 33.5 months
|
46.2%
24/52 • A median follow-up of 33.5 months
|
|
Renal and urinary disorders
Acute kidney injury
|
7.8%
4/51 • A median follow-up of 33.5 months
|
0.00%
0/52 • A median follow-up of 33.5 months
|
|
Renal and urinary disorders
Hematuria
|
5.9%
3/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
Renal and urinary disorders
Proteinuria
|
13.7%
7/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
Renal and urinary disorders
Urinary frequency
|
7.8%
4/51 • A median follow-up of 33.5 months
|
3.8%
2/52 • A median follow-up of 33.5 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.9%
2/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
21.6%
11/51 • A median follow-up of 33.5 months
|
30.8%
16/52 • A median follow-up of 33.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
51.0%
26/51 • A median follow-up of 33.5 months
|
48.1%
25/52 • A median follow-up of 33.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
41.2%
21/51 • A median follow-up of 33.5 months
|
34.6%
18/52 • A median follow-up of 33.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
47.1%
24/51 • A median follow-up of 33.5 months
|
53.8%
28/52 • A median follow-up of 33.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
13.7%
7/51 • A median follow-up of 33.5 months
|
11.5%
6/52 • A median follow-up of 33.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
13.7%
7/51 • A median follow-up of 33.5 months
|
11.5%
6/52 • A median follow-up of 33.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.9%
2/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory, thoracic and mediastinal disorders
|
5.9%
3/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.8%
5/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
23.5%
12/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.9%
2/51 • A median follow-up of 33.5 months
|
11.5%
6/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
49.0%
25/51 • A median follow-up of 33.5 months
|
38.5%
20/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.7%
8/51 • A median follow-up of 33.5 months
|
21.2%
11/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.9%
2/51 • A median follow-up of 33.5 months
|
11.5%
6/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.8%
6/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
5.9%
3/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
11.8%
6/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.0%
1/51 • A median follow-up of 33.5 months
|
7.7%
4/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
5.9%
3/51 • A median follow-up of 33.5 months
|
11.5%
6/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
5.9%
3/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.9%
2/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.8%
4/51 • A median follow-up of 33.5 months
|
15.4%
8/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.7%
7/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
11.8%
6/51 • A median follow-up of 33.5 months
|
26.9%
14/52 • A median follow-up of 33.5 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.9%
2/51 • A median follow-up of 33.5 months
|
5.8%
3/52 • A median follow-up of 33.5 months
|
|
Vascular disorders
Flushing
|
2.0%
1/51 • A median follow-up of 33.5 months
|
9.6%
5/52 • A median follow-up of 33.5 months
|
|
Vascular disorders
Hematoma
|
5.9%
3/51 • A median follow-up of 33.5 months
|
3.8%
2/52 • A median follow-up of 33.5 months
|
|
Vascular disorders
Hot flashes
|
5.9%
3/51 • A median follow-up of 33.5 months
|
1.9%
1/52 • A median follow-up of 33.5 months
|
|
Vascular disorders
Hypertension
|
37.3%
19/51 • A median follow-up of 33.5 months
|
21.2%
11/52 • A median follow-up of 33.5 months
|
|
Vascular disorders
Hypotension
|
7.8%
4/51 • A median follow-up of 33.5 months
|
3.8%
2/52 • A median follow-up of 33.5 months
|
|
Vascular disorders
Thromboembolic event
|
27.5%
14/51 • A median follow-up of 33.5 months
|
15.4%
8/52 • A median follow-up of 33.5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place