Trial Outcomes & Findings for Outcome of Cetrotide Therapy for Management of Women at High-risk of Ovarian Hyperstimulation Syndrome (NCT NCT02823080)
NCT ID: NCT02823080
Last Updated: 2017-03-30
Results Overview
Serum E2 levels (Serum E2 level in picograms/ml) were evaluated daily.
Recruitment status
UNKNOWN
Study phase
PHASE2/PHASE3
Target enrollment
48 participants
Primary outcome timeframe
8 days
Results posted on
2017-03-30
Participant Flow
Participant milestones
| Measure |
Cetrotide
study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD(maximal ovarian diameter) were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
no Cetrotide
control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Outcome of Cetrotide Therapy for Management of Women at High-risk of Ovarian Hyperstimulation Syndrome
Baseline characteristics by cohort
| Measure |
Cetrotide
n=24 Participants
study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
no Cetrotide
n=24 Participants
control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
48 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
48 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
24 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
48 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Egypt
|
12 participants
n=39 Participants
|
12 participants
n=41 Participants
|
24 participants
n=35 Participants
|
|
Region of Enrollment
Saudi Arabia
|
12 participants
n=39 Participants
|
12 participants
n=41 Participants
|
24 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 8 daysSerum E2 levels (Serum E2 level in picograms/ml) were evaluated daily.
Outcome measures
| Measure |
no Cetrotide
n=24 Participants
control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
Cetrotide
n=24 Participants
study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
|---|---|---|
|
Daily Serum E2 Levels
Day-7
|
1275 picograms/ml
Standard Deviation 588
|
969 picograms/ml
Standard Deviation 118
|
|
Daily Serum E2 Levels
Day-0
|
5004 picograms/ml
Standard Deviation 792
|
4761 picograms/ml
Standard Deviation 940
|
|
Daily Serum E2 Levels
Day-1
|
4212 picograms/ml
Standard Deviation 950
|
3397 picograms/ml
Standard Deviation 1361
|
|
Daily Serum E2 Levels
Day-2
|
3620 picograms/ml
Standard Deviation 1037
|
2772 picograms/ml
Standard Deviation 1456
|
|
Daily Serum E2 Levels
Day-3
|
3592 picograms/ml
Standard Deviation 862
|
2067 picograms/ml
Standard Deviation 900
|
|
Daily Serum E2 Levels
Day-4
|
2570 picograms/ml
Standard Deviation 914
|
1452 picograms/ml
Standard Deviation 617
|
|
Daily Serum E2 Levels
Day-5
|
1914 picograms/ml
Standard Deviation 965
|
1173 picograms/ml
Standard Deviation 180
|
|
Daily Serum E2 Levels
Day-6
|
1544 picograms/ml
Standard Deviation 812
|
1173 picograms/ml
Standard Deviation 180
|
|
Daily Serum E2 Levels
Day-8
|
1044 picograms/ml
Standard Deviation 200
|
902 picograms/ml
Standard Deviation 66
|
PRIMARY outcome
Timeframe: 8 daysMOD (maximal ovarian diameter in mm) were evaluated daily.
Outcome measures
| Measure |
no Cetrotide
n=24 Participants
control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
Cetrotide
n=24 Participants
study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
|---|---|---|
|
Daily Maximal Ovarian Diameter
Day-0
|
10.4 mm
Standard Deviation 5.8
|
9.4 mm
Standard Deviation 4.5
|
|
Daily Maximal Ovarian Diameter
Day-1
|
10.2 mm
Standard Deviation 5.6
|
9.3 mm
Standard Deviation 4.6
|
|
Daily Maximal Ovarian Diameter
Day-2
|
9.6 mm
Standard Deviation 4.6
|
9.1 mm
Standard Deviation 4.2
|
|
Daily Maximal Ovarian Diameter
Day-3
|
9.4 mm
Standard Deviation 4.9
|
8.7 mm
Standard Deviation 4.3
|
|
Daily Maximal Ovarian Diameter
Day-4
|
9.2 mm
Standard Deviation 4.7
|
8.5 mm
Standard Deviation 4.3
|
|
Daily Maximal Ovarian Diameter
Day-5
|
9 mm
Standard Deviation 4.6
|
7.8 mm
Standard Deviation 4
|
|
Daily Maximal Ovarian Diameter
Day-6
|
8.5 mm
Standard Deviation 4.6
|
7.5 mm
Standard Deviation 4.2
|
|
Daily Maximal Ovarian Diameter
Day-7
|
8.2 mm
Standard Deviation 4.5
|
7.3 mm
Standard Deviation 4
|
|
Daily Maximal Ovarian Diameter
Day-8
|
7.9 mm
Standard Deviation 4.2
|
7.1 mm
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 8 days.-All patients were clinically evaluated for the presence of abdominal pain and if present was graduated using a numerical pain visual analogue scale (VAS) with 0 means no pain and 10 means severe intolerable pain .
Outcome measures
| Measure |
no Cetrotide
n=24 Participants
control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
Cetrotide
n=24 Participants
study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
|---|---|---|
|
Daily Numerical Pain Visual Analogue Scale Score
Day-0
|
5.4 units on a scale
Standard Deviation 1.7
|
5.3 units on a scale
Standard Deviation 1.6
|
|
Daily Numerical Pain Visual Analogue Scale Score
Day-1
|
5 units on a scale
Standard Deviation 1.3
|
4.3 units on a scale
Standard Deviation 1.3
|
|
Daily Numerical Pain Visual Analogue Scale Score
Day-2
|
4.9 units on a scale
Standard Deviation 1.8
|
3.6 units on a scale
Standard Deviation 1
|
|
Daily Numerical Pain Visual Analogue Scale Score
Day-3
|
4.6 units on a scale
Standard Deviation 1.8
|
2.3 units on a scale
Standard Deviation 1.8
|
|
Daily Numerical Pain Visual Analogue Scale Score
Day-4
|
4.5 units on a scale
Standard Deviation 1.4
|
1.6 units on a scale
Standard Deviation 1.2
|
|
Daily Numerical Pain Visual Analogue Scale Score
Day-5
|
3.7 units on a scale
Standard Deviation 2
|
0.92 units on a scale
Standard Deviation 1.1
|
|
Daily Numerical Pain Visual Analogue Scale Score
Day-6
|
2.4 units on a scale
Standard Deviation 1.1
|
0.33 units on a scale
Standard Deviation 0.6
|
|
Daily Numerical Pain Visual Analogue Scale Score
Day-7
|
1.6 units on a scale
Standard Deviation 1.1
|
0.17 units on a scale
Standard Deviation 0.38
|
|
Daily Numerical Pain Visual Analogue Scale Score
Day-8
|
1.1 units on a scale
Standard Deviation 1.7
|
0.13 units on a scale
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: 0-8 days.Blood samples were obtained under complete aseptic condition for determination of hematocrits value (Ht%)
Outcome measures
| Measure |
no Cetrotide
n=24 Participants
control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
Cetrotide
n=24 Participants
study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
|---|---|---|
|
Daily Hematocrits Value
Day-0
|
39.8 percentge
Standard Deviation 4.2
|
42.2 percentge
Standard Deviation 5.2
|
|
Daily Hematocrits Value
Day-3
|
38.8 percentge
Standard Deviation 3.3
|
38.7 percentge
Standard Deviation 3.3
|
|
Daily Hematocrits Value
Day-6
|
38 percentge
Standard Deviation 3.1
|
37.3 percentge
Standard Deviation 2.5
|
|
Daily Hematocrits Value
Day-8
|
37.5 percentge
Standard Deviation 1.5
|
36.8 percentge
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 0-8 days-US detected severity grades of ascites determined at Day -0, Day -3 and Day -8.
Outcome measures
| Measure |
no Cetrotide
n=24 Participants
control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
Cetrotide
n=24 Participants
study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
|---|---|---|
|
Ultrasound Detected Severity Grades of Ascites From Days 0-8
Low grade ascitis at Day-0
|
6 US detected ascitis
|
8 US detected ascitis
|
|
Ultrasound Detected Severity Grades of Ascites From Days 0-8
Low grade ascitis at Day-3
|
13 US detected ascitis
|
18 US detected ascitis
|
|
Ultrasound Detected Severity Grades of Ascites From Days 0-8
Low grade ascitis at Day-8
|
17 US detected ascitis
|
21 US detected ascitis
|
|
Ultrasound Detected Severity Grades of Ascites From Days 0-8
moderate grade ascitis at Day-0
|
18 US detected ascitis
|
16 US detected ascitis
|
|
Ultrasound Detected Severity Grades of Ascites From Days 0-8
moderate grade ascitis at Day-3
|
8 US detected ascitis
|
6 US detected ascitis
|
|
Ultrasound Detected Severity Grades of Ascites From Days 0-8
moderate grade ascitis at Day-8
|
5 US detected ascitis
|
3 US detected ascitis
|
|
Ultrasound Detected Severity Grades of Ascites From Days 0-8
severe grade ascitis at Day-0
|
0 US detected ascitis
|
0 US detected ascitis
|
|
Ultrasound Detected Severity Grades of Ascites From Days 0-8
severe grade ascitis at Day-3
|
3 US detected ascitis
|
0 US detected ascitis
|
|
Ultrasound Detected Severity Grades of Ascites From Days 0-8
severe grade ascitis at Day-8
|
2 US detected ascitis
|
0 US detected ascitis
|
SECONDARY outcome
Timeframe: 0 -8days.TLC(x 1ooo cells/ml)
Outcome measures
| Measure |
no Cetrotide
n=24 Participants
control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
Cetrotide
n=24 Participants
study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
|---|---|---|
|
Daily Total Leucocytic Count
Day-0
|
11.6 1000 cells/ml
Standard Deviation 3.7
|
12.75 1000 cells/ml
Standard Deviation 3.1
|
|
Daily Total Leucocytic Count
Day-3
|
11.3 1000 cells/ml
Standard Deviation 3.6
|
11.5 1000 cells/ml
Standard Deviation 2.8
|
|
Daily Total Leucocytic Count
Day-6
|
11.2 1000 cells/ml
Standard Deviation 3.6
|
11 1000 cells/ml
Standard Deviation 1.9
|
|
Daily Total Leucocytic Count
Day-8
|
10.1 1000 cells/ml
Standard Deviation 2.2
|
9.75 1000 cells/ml
Standard Deviation 3.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-6 days-severity grades of gastrointestinal manifestations determined at Day -0,Day -3 and Day -6.
Outcome measures
| Measure |
no Cetrotide
n=24 Participants
control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
Cetrotide
n=24 Participants
study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
|
|---|---|---|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
severe Abdominal distension at Day-3
|
0 GI manifestations
|
0 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
Nil Nausea at Day-0
|
6 GI manifestations
|
5 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
mild Nausea at Day-0
|
7 GI manifestations
|
8 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
moderate Nausea at Day-0
|
6 GI manifestations
|
7 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
severe Nausea at Day-0
|
5 GI manifestations
|
4 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
Nil Nausea at Day-3
|
12 GI manifestations
|
19 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
mild Nausea at Day-3
|
8 GI manifestations
|
4 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
moderate Nausea at Day-3
|
4 GI manifestations
|
1 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
severe Nausea at Day-3
|
0 GI manifestations
|
0 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
Nil Nausea at Day-6
|
22 GI manifestations
|
24 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
mild Nausea at Day-6
|
2 GI manifestations
|
0 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
moderate Nausea at Day-6
|
0 GI manifestations
|
0 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
severe Nausea at Day-6
|
0 GI manifestations
|
0 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
Nil Vomiting at Day-0
|
12 GI manifestations
|
14 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
mild Vomiting at Day-0
|
8 GI manifestations
|
7 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
moderatel Vomiting at Day-0
|
4 GI manifestations
|
2 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
severe Vomiting at Day-0
|
0 GI manifestations
|
1 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
Nil Vomiting at Day-3
|
20 GI manifestations
|
24 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
mild Vomiting at Day-3
|
4 GI manifestations
|
0 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
moderate Vomiting at Day-3
|
0 GI manifestations
|
0 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
severe Vomiting at Day-3
|
0 GI manifestations
|
0 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
Nil Vomiting at Day-6
|
24 GI manifestations
|
24 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
mild Vomiting at Day-6
|
0 GI manifestations
|
0 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
moderat Vomiting at Day-6
|
0 GI manifestations
|
0 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
severe Vomiting at Day-6
|
0 GI manifestations
|
0 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
Nil Abdominal distension at Day-0
|
4 GI manifestations
|
5 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
mild Abdominal distension at Day-0
|
7 GI manifestations
|
8 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
moderate Abdominal distension at Day-0
|
10 GI manifestations
|
9 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
severe Abdominal distension at Day-0
|
3 GI manifestations
|
2 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
Nil Abdominal distension at Day-3
|
9 GI manifestations
|
15 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
mild Abdominal distension at Day-3
|
12 GI manifestations
|
8 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
moderate Abdominal distension at Day-3
|
3 GI manifestations
|
1 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
Nil Abdominal distension at Day-6
|
20 GI manifestations
|
24 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
mild Abdominal distension at Day-6
|
4 GI manifestations
|
0 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
moderate Abdominal distension at Day-6
|
0 GI manifestations
|
0 GI manifestations
|
|
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
severe Abdominal distension at Day-6
|
0 GI manifestations
|
0 GI manifestations
|
Adverse Events
Cetrotide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
no Cetrotide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place