Trial Outcomes & Findings for Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions (NCT NCT03861065)
NCT ID: NCT03861065
Last Updated: 2026-04-17
Results Overview
The number of surgical wounds that remained closed at postoperative day #30 after tertiary wound closure as compared to historical controls receiving a secondary wound closure.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
30 days after tertiary wound closure
Results posted on
2026-04-17
Participant Flow
The study enrolled patients to receive tertiary wound closure; historical controls who received secondary wound closure during 2018 were selected for comparison. Historical Controls were not considered enrolled and were only used for comparison.
Participant milestones
| Measure |
Tertiary Wound Closure
In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound.
Tertiary Wound Closure: The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery.
|
Historical Wound Closure
The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure").
Historical Wound Closure: Participants wounds are left partially open to heal.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
20
|
|
Overall Study
COMPLETED
|
5
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Tertiary Wound Closure
In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound.
Tertiary Wound Closure: The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery.
|
Historical Wound Closure
The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure").
Historical Wound Closure: Participants wounds are left partially open to heal.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
0
|
Baseline Characteristics
Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions
Baseline characteristics by cohort
| Measure |
Tertiary Wound Closure
n=8 Participants
In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound.
Tertiary Wound Closure: The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery.
|
Historical Wound Closure
n=20 Participants
The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure").
Historical Wound Closure: Participants wounds are left partially open to heal.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.25 years
STANDARD_DEVIATION 19.3 • n=130 Participants
|
58.95 years
STANDARD_DEVIATION 11.1 • n=132 Participants
|
57.32 years
STANDARD_DEVIATION 13.8 • n=130 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=130 Participants
|
20 Participants
n=132 Participants
|
28 Participants
n=130 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=130 Participants
|
3 Participants
n=132 Participants
|
3 Participants
n=130 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=130 Participants
|
14 Participants
n=132 Participants
|
21 Participants
n=130 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=130 Participants
|
3 Participants
n=132 Participants
|
4 Participants
n=130 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=130 Participants
|
20 participants
n=132 Participants
|
28 participants
n=130 Participants
|
PRIMARY outcome
Timeframe: 30 days after tertiary wound closurePopulation: Three women did not meet intraoperative criteria and were not treated per protocol. One woman died 11 days after surgery due to respiratory failure; the primary outcome could not be measured at 30 days.
The number of surgical wounds that remained closed at postoperative day #30 after tertiary wound closure as compared to historical controls receiving a secondary wound closure.
Outcome measures
| Measure |
Tertiary Wound Closure
n=4 Participants
In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound.
Tertiary Wound Closure: The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery.
|
Historical Wound Closure
n=20 Participants
The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure").
Historical Wound Closure: Participants wounds are left partially open to heal.
|
|---|---|---|
|
Number of Participants With Wound Closures Comparing Tertiary Wound Closure Versus Historical Controls Postoperative Day 30
|
4 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 30 days after tertiary wound closurePopulation: Three women did not meet intraoperative criteria and were not treated per protocol. One woman died 11 days post-surgery from respiratory failure; she is excluded from this analysis because she was not alive at 30 days post surgery.
The number of Surgical Site Infections (SSI) within 30 days using a tertiary closure technique compared to historical controls receiving a secondary would closure.
Outcome measures
| Measure |
Tertiary Wound Closure
n=4 Participants
In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound.
Tertiary Wound Closure: The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery.
|
Historical Wound Closure
n=20 Participants
The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure").
Historical Wound Closure: Participants wounds are left partially open to heal.
|
|---|---|---|
|
Number of Participants With Surgical Site Infections (SSI) for Tertiary Technique Versus Historical Controls
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 3 months after surgeryPopulation: Three women did not meet intraoperative criteria and were not treated per protocol. One woman died 11 days after surgery, and is excluded from this analysis because her LOS was censored by her death.
The length of stay as defined by the time from surgery to discharge as compared to historical controls receiving a secondary would closure.
Outcome measures
| Measure |
Tertiary Wound Closure
n=4 Participants
In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound.
Tertiary Wound Closure: The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery.
|
Historical Wound Closure
n=20 Participants
The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure").
Historical Wound Closure: Participants wounds are left partially open to heal.
|
|---|---|---|
|
Length of Hospital Stay
|
3.5 days
Interval 3.0 to 9.5
|
5 days
Interval 3.5 to 6.5
|
SECONDARY outcome
Timeframe: Up to 30 days after surgeryPopulation: Three women did not meet intraoperative criteria and were not treated per protocol. One woman died 11 days post-surgery from respiratory failure and was excluded from this analysis because she was not alive 30 days post-surgery.
The proportion of patients that return to hospital within 30 days of surgery.
Outcome measures
| Measure |
Tertiary Wound Closure
n=4 Participants
In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound.
Tertiary Wound Closure: The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery.
|
Historical Wound Closure
n=20 Participants
The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure").
Historical Wound Closure: Participants wounds are left partially open to heal.
|
|---|---|---|
|
Proportion of Patients Returning After Surgery
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 3 months after tertiary wound closurePopulation: Three women did not meet intraoperative criteria and were not treated per protocol. One woman died 11 days post surgery and did not complete the SF-36. Historical controls did not complete the SF-36 and were not participants for this study and will not be included as an arm of this study.
The quality of life is estimated only in patients receiving a tertiary wound closure. Groups of questions were transformed into a 0-100 scale for eight domains. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Tertiary Wound Closure
n=4 Participants
In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound.
Tertiary Wound Closure: The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery.
|
Historical Wound Closure
n=3 Participants
The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure").
Historical Wound Closure: Participants wounds are left partially open to heal.
|
|---|---|---|
|
Quality of Life Questionnaire SF-36 (Version 1)
Physical Functioning Domain
|
37.22 score on a scale
Standard Deviation 16.9
|
40.36 score on a scale
Standard Deviation 22.2
|
|
Quality of Life Questionnaire SF-36 (Version 1)
Role-Physical Domain
|
31.05 score on a scale
Standard Deviation 3.7
|
32.08 score on a scale
Standard Deviation 3.7
|
|
Quality of Life Questionnaire SF-36 (Version 1)
Body Pain Domain
|
44.34 score on a scale
Standard Deviation 8.8
|
48.47 score on a scale
Standard Deviation 9.4
|
|
Quality of Life Questionnaire SF-36 (Version 1)
General Health Domain
|
40.47 score on a scale
Standard Deviation 14.8
|
44.33 score on a scale
Standard Deviation 13.4
|
|
Quality of Life Questionnaire SF-36 (Version 1)
Vitality Domain
|
42.99 score on a scale
Standard Deviation 14.96
|
47.67 score on a scale
Standard Deviation 13.3
|
|
Quality of Life Questionnaire SF-36 (Version 1)
Social Functioning Domain
|
39.5 score on a scale
Standard Deviation 20.5
|
49.9 score on a scale
Standard Deviation 12.5
|
|
Quality of Life Questionnaire SF-36 (Version 1)
Role-Emotional Domain
|
39.54 score on a scale
Standard Deviation 18.3
|
44.81 score on a scale
Standard Deviation 18.3
|
|
Quality of Life Questionnaire SF-36 (Version 1)
Mental Health Domain
|
51.3 score on a scale
Standard Deviation 14.4
|
55.56 score on a scale
Standard Deviation 12.4
|
Adverse Events
Tertiary Wound Closure
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Tertiary Wound Closure
n=5 participants at risk
In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound.
Tertiary Wound Closure: The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery.
|
|---|---|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Investigations
Urine output decreased
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
Other adverse events
| Measure |
Tertiary Wound Closure
n=5 participants at risk
In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound.
Tertiary Wound Closure: The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
4/5 • Number of events 7 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
40.0%
2/5 • Number of events 3 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Cardiac disorders
Sinus tachycardia
|
40.0%
2/5 • Number of events 2 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Number of events 2 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Infections and infestations
Thrush
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Investigations
Blood bicarbonate decreased
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Investigations
Blood bilirubin increased
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Investigations
Creatinine increased
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Investigations
White blood cell decreased
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
2/5 • Number of events 2 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
80.0%
4/5 • Number of events 5 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
40.0%
2/5 • Number of events 2 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
40.0%
2/5 • Number of events 2 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Nervous system disorders
Somnolence
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
20.0%
1/5 • Number of events 2 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Number of events 1 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
|
Vascular disorders
Hypotension
|
40.0%
2/5 • Number of events 2 • The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
|
Additional Information
Study Nurse
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-713-3539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place