Trial Outcomes & Findings for Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer (NCT NCT00416455)
NCT ID: NCT00416455
Last Updated: 2019-07-23
Results Overview
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
384 participants
Primary outcome timeframe
Before surgery (FDG-PET-CT) and after surgery (pathology)
Results posted on
2019-07-23
Participant Flow
The study was activated on 9/24/2007. Combidex MRI was discontinued on 11/09/2009 due to lack of study drug. GOG 0233 (NCT 00416455) closed to accrual on 6/21/2013.
Participant milestones
| Measure |
Cervical Cancer Patients
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Overall Study
STARTED
|
169
|
215
|
|
Overall Study
COMPLETED
|
153
|
207
|
|
Overall Study
NOT COMPLETED
|
16
|
8
|
Reasons for withdrawal
| Measure |
Cervical Cancer Patients
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Overall Study
PET / CT not done
|
3
|
5
|
|
Overall Study
PET / CT poor quality
|
2
|
1
|
|
Overall Study
Inadequate pathology
|
11
|
2
|
Baseline Characteristics
Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Cervical Cancer Patients
n=153 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=207 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
58 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
153 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before surgery (FDG-PET-CT) and after surgery (pathology)Population: Abdominal positive and negative patients. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers.
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
|
50 percentage of participants
Interval 44.0 to 56.0
|
65 percentage of participants
Interval 57.0 to 72.0
|
PRIMARY outcome
Timeframe: Before surgery (FDG-PET/CT) and after surgery (pathology)Population: Patients with abdominal positive and negative lymph nodes. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers.
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
|
85 percentage of participants
Interval 80.0 to 89.0
|
88 percentage of participants
Interval 83.0 to 92.0
|
SECONDARY outcome
Timeframe: Before surgery (DCT) and after surgery (pathology)Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported sensitivity is reader-averaged sensitivity.
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
|
83 percentage of participants
Interval 78.0 to 87.0
|
65 percentage of participants
Interval 57.0 to 72.0
|
SECONDARY outcome
Timeframe: Before surgery (FDG-PET/CT) and after surgery (pathology)Population: Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
The specificity is defined as the percentage of patients who test without lymph node metastases in pelvis by pre-operative PET/CT among the patients who do not have lymph node metastases in pelvis identified by post-surgery pathology. The reported specificity is reader-averaged specificity.
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
|
63 percentage of participants
Interval 54.0 to 70.0
|
93 percentage of participants
Interval 86.0 to 96.0
|
SECONDARY outcome
Timeframe: Before surgery (FDG-PET/CT) and after surgery (pathology)Population: Patients with abdominal positive and negative lymph nodes. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported sensitivity is reader-average sensitivity.
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
|
81 Percentage of participants
Interval 77.0 to 85.0
|
63 Percentage of participants
Interval 56.0 to 70.0
|
SECONDARY outcome
Timeframe: Before surgery (FDG-PET/CT) and after surgery (pathology)Population: Cervical cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported specificity is reader-averaged specificity.
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
|
69 percentage of participants
Interval 59.0 to 77.0
|
83 percentage of participants
Interval 76.0 to 88.0
|
SECONDARY outcome
Timeframe: Before surgery (FDG-PET/CT) and after surgery (pathology)Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative CT alone among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
|
42 percentage of participants
Interval 36.0 to 48.0
|
50 percentage of participants
Interval 43.0 to 58.0
|
SECONDARY outcome
Timeframe: Before surgery (FDG-PET/CT) and after surgery (pathology)Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative either CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone
|
79 percentage of participants
Interval 73.0 to 83.0
|
48 percentage of participants
Interval 41.0 to 56.0
|
SECONDARY outcome
Timeframe: Before surgery (FDG-PET/CT) and after surgery (pathology)Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative by CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
|
77 percentage of participants
Interval 73.0 to 81.0
|
54 percentage of participants
Interval 47.0 to 61.0
|
SECONDARY outcome
Timeframe: Before surgery (FDG-PET/CT) and after surgery (pathology)Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
|
89 percentage of participants
Interval 84.0 to 92.0
|
93 percentage of participants
Interval 89.0 to 96.0
|
SECONDARY outcome
Timeframe: Before surgery (FDG-PET/CT) and after surgery (pathology)Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative byCT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone
|
62 percentage of participants
Interval 53.0 to 69.0
|
89 percentage of participants
Interval 82.0 to 94.0
|
SECONDARY outcome
Timeframe: Before surgery (FDG-PET/CT) and after surgery (pathology)Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
|
63 percentage of participants
Interval 54.0 to 72.0
|
85 percentage of participants
Interval 78.0 to 90.0
|
SECONDARY outcome
Timeframe: Before surgery (FDG-PET/CT) and after surgery (pathology)Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes
|
9 percentage of participants
|
10 percentage of participants
|
SECONDARY outcome
Timeframe: Before surgery (FDG-PET/CT) and after surgery (pathology)Population: Particpants with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Outcome measures
| Measure |
Cervical Cancer Patients
n=80 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=49 Participants
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node
|
10 percentage of participants
|
6 percentage of participants
|
SECONDARY outcome
Timeframe: During surgery and up to 30 days after surgery.Population: All loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy
Number of participants with cervical cancer and a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.
Outcome measures
| Measure |
Cervical Cancer Patients
n=127 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Leukopenia
|
1 Participants
|
—
|
|
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Thrombocytopenia
|
1 Participants
|
—
|
|
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Anemia
|
7 Participants
|
—
|
|
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Other Hematologic
|
1 Participants
|
—
|
|
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Dermatologic
|
1 Participants
|
—
|
|
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Gastrointestinal
|
4 Participants
|
—
|
|
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Infection
|
9 Participants
|
—
|
|
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Lymphatics
|
5 Participants
|
—
|
|
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Metabolic
|
3 Participants
|
—
|
|
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Musculoskeletal
|
1 Participants
|
—
|
|
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Pain
|
2 Participants
|
—
|
|
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Vascular
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 4 weeks from PET/CTPopulation: All Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy and the reason they experienced a delay in the initiation of chemo-radiation
Number of cervical cancer patients with reasons of delay in the initiation of chemo-radiation therapy
Outcome measures
| Measure |
Cervical Cancer Patients
n=127 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients
Surgery related adverse events
|
3 Participants
|
—
|
|
Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients
Patient preference/scheduling difficulty
|
21 Participants
|
—
|
|
Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients
Other
|
6 Participants
|
—
|
|
Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients
Not reported
|
3 Participants
|
—
|
|
Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients
No Delay
|
94 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 6 weeks after surgeryPopulation: Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy who experienced an interruption in radiation therapy
Number of cervical cancer patients with reasons of interruption in radiation therapy
Outcome measures
| Measure |
Cervical Cancer Patients
n=127 Participants
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Cause of Interruption in Radiation Therapy in Cervical Cancer Patients
Chemoradiation related adverse events
|
1 Participants
|
—
|
|
Cause of Interruption in Radiation Therapy in Cervical Cancer Patients
Patient preference/scheduling difficulty
|
1 Participants
|
—
|
|
Cause of Interruption in Radiation Therapy in Cervical Cancer Patients
Other
|
9 Participants
|
—
|
|
Cause of Interruption in Radiation Therapy in Cervical Cancer Patients
Not reported
|
14 Participants
|
—
|
|
Cause of Interruption in Radiation Therapy in Cervical Cancer Patients
No interruption
|
102 Participants
|
—
|
Adverse Events
Cervical Cancer Patients
Serious events: 17 serious events
Other events: 108 other events
Deaths: 0 deaths
Endometrial Cancer Patients
Serious events: 19 serious events
Other events: 132 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervical Cancer Patients
n=169 participants at risk
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=215 participants at risk
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Cardiac disorders
Conduction Abnml: Asystole
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Flutter
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Cardiac disorders
Hypotension
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Death No Ctcae Term - Death Nos
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Fistula, Gi - Colon/Cecum/Appendix
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Obstruction, Gi - Colon
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
1.4%
3/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Hemorrhage With Surgery
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Hemorrhage, Gi - Abdomen Nos
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Lung (Pneumonia)
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Infection - Other
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Pelvis Nos
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Lymphatic
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Small Bowel Nos
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Abdomen Nos
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Skin (Cellulitis)
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Blood and lymphatic system disorders
Lymphocele
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Gallbladder
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Abdominal Pain Nos
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Renal and urinary disorders
Leak, Gu - Ureter
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
2nd Mal: Poss. Related To Cancer Rx
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Surgical and medical procedures
Intra-Op Injury: Other
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Tumor Flare
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
Other adverse events
| Measure |
Cervical Cancer Patients
n=169 participants at risk
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
Endometrial Cancer Patients
n=215 participants at risk
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrophils
|
3.6%
6/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
2.8%
6/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Blood and lymphatic system disorders
Platelets
|
11.2%
19/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
5.1%
11/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
1.4%
3/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Blood and lymphatic system disorders
Leukocytes
|
14.2%
24/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
6.0%
13/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Blood and lymphatic system disorders
Hemoglobin
|
47.3%
80/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
40.9%
88/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Cardiac disorders
Palpitations
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Cardiac disorders
Conduction Abnml: Asystole
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Flutter
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Tachycardia
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Bradycardia
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Cardiac disorders
Hypertension
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Cardiac disorders
Hypotension
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Inr
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Coagulopathy - Other
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Weight Gain
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Fever
|
3.6%
6/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
1.9%
4/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Weight Loss
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Rigors/Chills
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Fatigue
|
4.1%
7/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
5.1%
11/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Insomnia
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Death No Ctcae Term - Death Nos
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Skin and subcutaneous tissue disorders
Wound Complication, Non-Infectious
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
3.3%
7/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Endocrine disorders
Hot Flashes
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Fistula, Gi - Colon/Cecum/Appendix
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Heartburn
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Leak, Gi - Leak Nos
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Fistula, Gi - Jejunum
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Ileus
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
3.3%
7/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Distention
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Dry Mouth
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Colitis
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Obstruction, Gi - Jejunum
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
8/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
3.3%
7/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Anorexia
|
5.3%
9/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
3.7%
8/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Dehydration
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Constipation
|
7.1%
12/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
4.7%
10/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Nausea
|
10.7%
18/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
5.6%
12/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
6/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
1.9%
4/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
3.6%
6/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Hemorrhage, Gi - Upper Gi Nos
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Hematoma
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Hemorrhage, Gi - Abdomen Nos
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Petechiae
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
1.4%
3/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Lung (Pneumonia)
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Colon
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
2.4%
4/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Infection - Other
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Colitis, Infectious (Eg.C. Difficile)
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Pelvis Nos
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Upper Airway Nos
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Bronchus
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
1.4%
3/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Wound
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Abdomen Nos
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf Unknown Anc: Skin (Cellulitis)
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Blood and lymphatic system disorders
Lymphocele
|
3.6%
6/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Blood and lymphatic system disorders
Edema: Viscera
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Blood and lymphatic system disorders
Edema: Trunk/Genital
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Blood and lymphatic system disorders
Edema: Limb
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
2.3%
5/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Blood and lymphatic system disorders
Chyle Or Lymph Leakage
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Ast
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
1.4%
3/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Proteinuria
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Creatinine
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
4.2%
9/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.0%
5/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
8.8%
19/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Alt
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
1.9%
4/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
3.3%
7/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
3.3%
7/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.1%
7/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
8.4%
18/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.9%
15/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
24.2%
52/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
2.3%
5/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.3%
14/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
23.7%
51/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
9/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
12.6%
27/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
1.4%
3/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.4%
4/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
4.2%
9/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Necrosis - Abdomen
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Nervous system disorders
Mental Status
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Nervous system disorders
Mood Alteration - Depression
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Nervous system disorders
Dizziness
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Nervous system disorders
Neuropathy-Sensory
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
1.4%
3/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Nervous system disorders
Neuropathy-Motor
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain - Other
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
1.4%
3/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Urethra
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Pelvis
|
3.0%
5/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Breast
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Vagina
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Chest /Thorax Nos
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Chest Wall
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Head/Headache
|
2.4%
4/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Extremity-Limb
|
2.4%
4/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Back
|
2.4%
4/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Joint
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Gallbladder
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Abdominal Pain Nos
|
7.1%
12/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
6.5%
14/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Skin
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Muscle
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Pain: Anus
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Respiratory, thoracic and mediastinal disorders
Edema, Larynx
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Renal and urinary disorders
Leak, Gu - Ureter
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Renal and urinary disorders
Cystitis
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Renal and urinary disorders
Urinary Retention
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.00%
0/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Renal and urinary disorders
Incontinence, Urinary
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Renal and urinary disorders
Urinary Frequency
|
1.8%
3/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
1.2%
2/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Surgical and medical procedures
Intra-Op Injury: Vein-Inferior Vena Cava
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Surgical and medical procedures
Intra-Op Injury: Bladder
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
General disorders
Flu-Like Syndrome
|
0.00%
0/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
0.59%
1/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.93%
2/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
2.4%
4/169 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
0.47%
1/215 • All Adverse Events (AEs) occurring within 30 days of surgery are reported
|
Additional Information
Angela M. Kuras, Associate Director of Data Management
NRG Oncology Statistics and Data Management Center
Phone: 716-845-7733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60