Trial Outcomes & Findings for Accelerating Gastrointestinal Recovery (NCT NCT01704651)
NCT ID: NCT01704651
Last Updated: 2016-10-24
Results Overview
Length of stay = date/time of hospital dismissal - date/time of end of surgery
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
146 participants
Primary outcome timeframe
Patients will be followed for the duration of their hospital stay, an expected average of 5 days
Results posted on
2016-10-24
Participant Flow
The study took place at Mayo Clinic in Rochester, Minnesota from January 2013 to June 2015.
Participant milestones
| Measure |
Alvimopan
Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
|
Placebo
Perioperative administration of placebo, at same dosing interval as study drug.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
75
|
|
Overall Study
COMPLETED
|
66
|
68
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Alvimopan
Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
|
Placebo
Perioperative administration of placebo, at same dosing interval as study drug.
|
|---|---|---|
|
Overall Study
Pre-op withdrawal by subject
|
1
|
1
|
|
Overall Study
Pre-op change in treatment plan
|
1
|
4
|
|
Overall Study
Nasogastric tube placement in surgery
|
1
|
1
|
|
Overall Study
Post-op did not have laparotomy
|
2
|
1
|
Baseline Characteristics
Accelerating Gastrointestinal Recovery
Baseline characteristics by cohort
| Measure |
Alvimopan
n=66 Participants
Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
|
Placebo
n=68 Participants
Perioperative administration of placebo, at same dosing interval as study drug.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
68 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Surgery Type
Primary surgery
|
45 participants
n=5 Participants
|
46 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Surgery Type
Interval debulking
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Surgery Type
Secondary debulking
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Cancer Stage
I/II
|
17 participants
n=5 Participants
|
8 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Cancer Stage
III/IV
|
33 participants
n=5 Participants
|
40 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Cancer Stage
Other non-ovarian primary cancers
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Cancer Stage
Benign pelvic masses
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Cancer Stage
Recurrent disease
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Residual Disease
No
|
48 participants
n=5 Participants
|
50 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Residual Disease
Yes, measurable (</= 1 cm)
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Residual Disease
Yes, suboptimal (>1 cm, limited sites)
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Residual Disease
Yes, extensive (multiple sites/organs)
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients will be followed for the duration of their hospital stay, an expected average of 5 daysPopulation: Intent to Treat analysis
Length of stay = date/time of hospital dismissal - date/time of end of surgery
Outcome measures
| Measure |
Alvimopan
n=66 Participants
Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
|
Placebo
n=68 Participants
Perioperative administration of placebo, at same dosing interval as study drug.
|
|---|---|---|
|
Postoperative Length of Hospital Stay
|
4.4 days
Standard Deviation 2.7
|
4.3 days
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Patients will be followed for 30 days postopPopulation: Intent to treat analysis
Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.
Outcome measures
| Measure |
Alvimopan
n=66 Participants
Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
|
Placebo
n=68 Participants
Perioperative administration of placebo, at same dosing interval as study drug.
|
|---|---|---|
|
Postoperative Ileus Incidence
|
7 participants
|
13 participants
|
Adverse Events
Alvimopan
Serious events: 9 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo
Serious events: 10 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alvimopan
n=66 participants at risk
Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
|
Placebo
n=68 participants at risk
Perioperative administration of oral placebo, at same dosing interval as study drug, starting with one dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days..
|
|---|---|---|
|
Cardiac disorders
Thromboembolic event
|
3.0%
2/66 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Renal and urinary disorders
Pelvic Fluid Collection
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Metabolism and nutrition disorders
Malaise (Failure to thrive)
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Nervous system disorders
Syncope
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Wound Dehiscence
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Wound Infection
|
3.0%
2/66 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Wound Complication
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Psychiatric disorders
Mania
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Cardiac disorders
Hematoma
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Metabolism and nutrition disorders
Sepsis
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
4.4%
3/68 • Number of events 3 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
Other adverse events
| Measure |
Alvimopan
n=66 participants at risk
Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
|
Placebo
n=68 participants at risk
Perioperative administration of oral placebo, at same dosing interval as study drug, starting with one dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days..
|
|---|---|---|
|
Cardiac disorders
Anemia
|
37.9%
25/66 • Number of events 25 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
39.7%
27/68 • Number of events 27 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Cardiac disorders
Arrhythmias
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
7.4%
5/68 • Number of events 5 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Cardiac disorders
Hypertension
|
4.5%
3/66 • Number of events 3 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Cardiac disorders
Thromboembolic event
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
4.4%
3/68 • Number of events 3 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Cardiac disorders
Pulmonary Edema
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
3.0%
2/66 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
8.8%
6/68 • Number of events 6 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Biliary Leak
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
27.3%
18/66 • Number of events 18 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
23.5%
16/68 • Number of events 16 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Dehydration
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
6/66 • Number of events 6 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
4.4%
3/68 • Number of events 3 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
10.6%
7/66 • Number of events 7 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
17.6%
12/68 • Number of events 12 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
30.3%
20/66 • Number of events 20 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
14.7%
10/68 • Number of events 10 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
9/66 • Number of events 9 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
11.8%
8/68 • Number of events 8 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Anorexia
|
6.1%
4/66 • Number of events 4 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Esophagitis
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Gastroparesis
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Enterocolitis
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Small Bowel Perforation
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Gastrointestinal disorders
Weight Loss
|
4.5%
3/66 • Number of events 3 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.1%
4/66 • Number of events 4 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Blood and lymphatic system disorders
Increased international normalized ratio (INR)
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Blood and lymphatic system disorders
Epistaxis
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphedema
|
7.6%
5/66 • Number of events 5 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
8.8%
6/68 • Number of events 6 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphangitis
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
12.1%
8/66 • Number of events 8 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
10.3%
7/68 • Number of events 7 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.0%
2/66 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Metabolism and nutrition disorders
Elevated Liver Enzymes
|
3.0%
2/66 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Metabolism and nutrition disorders
Fatigue
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Nervous system disorders
Syncope
|
3.0%
2/66 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
5.9%
4/68 • Number of events 4 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Nervous system disorders
Generalized Muscle Weakness
|
3.0%
2/66 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
4.4%
3/68 • Number of events 3 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Nervous system disorders
Delirium
|
4.5%
3/66 • Number of events 3 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Nervous system disorders
Somnolence
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Nervous system disorders
Tinnitus
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Nervous system disorders
Insomnia
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Nervous system disorders
Neuropathy, sensory
|
4.5%
3/66 • Number of events 3 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Nervous system disorders
Pain
|
9.1%
6/66 • Number of events 6 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
8.8%
6/68 • Number of events 6 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Nervous system disorders
Anxiety
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
5.9%
4/68 • Number of events 4 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Renal and urinary disorders
Cystotomy
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Renal and urinary disorders
Pelvic Abscess
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
10.6%
7/66 • Number of events 7 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
11.8%
8/68 • Number of events 8 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Renal and urinary disorders
Bladder Symptoms
|
9.1%
6/66 • Number of events 6 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
4.4%
3/68 • Number of events 3 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
General disorders
Allergic reaction to chemo
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/66 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.1%
4/66 • Number of events 4 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
7.4%
5/68 • Number of events 5 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.6%
5/66 • Number of events 5 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
7.4%
5/68 • Number of events 5 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.0%
2/66 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
0.00%
0/68 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonthorax
|
3.0%
2/66 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Wound Infection
|
10.6%
7/66 • Number of events 7 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
4.4%
3/68 • Number of events 3 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Wound Complication
|
6.1%
4/66 • Number of events 4 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
7.4%
5/68 • Number of events 5 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Vaginal Infection
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Blepharitis
|
0.00%
0/66 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.0%
2/66 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
2.9%
2/68 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
3.0%
2/66 • Number of events 2 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
1.5%
1/68 • Number of events 1 • Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place