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Trial Outcomes & Findings for Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer (NCT NCT03910387)

NCT ID: NCT03910387

Last Updated: 2025-12-16

Results Overview

Weight stability will be documented as percent weight change at 3 months compared to baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Baseline up to 3 months after study start

Results posted on

2025-12-16

Participant Flow

Participant milestones

Participant milestones
Measure
Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)
Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy Telotristat Ethyl: Given PO
Group 2 (gemcitabine/nab-paclitaxel)
Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy
Overall Study
STARTED
14
9
Overall Study
COMPLETED
14
9
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group 1 (Gemcitabine/Nab-paclitaxel and Telotristat Ethyl)
n=14 Participants
Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy Telotristat Ethyl: Given PO
Group 2 (Gemcitabine/Nab-paclitaxel)
n=9 Participants
Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy
Total
n=23 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=9 Participants
3 Participants
n=6 Participants
7 Participants
n=9 Participants
Age, Categorical
>=65 years
10 Participants
n=9 Participants
6 Participants
n=6 Participants
16 Participants
n=9 Participants
Sex: Female, Male
Female
3 Participants
n=9 Participants
4 Participants
n=6 Participants
7 Participants
n=9 Participants
Sex: Female, Male
Male
11 Participants
n=9 Participants
5 Participants
n=6 Participants
16 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants
n=9 Participants
8 Participants
n=6 Participants
21 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=9 Participants
1 Participants
n=6 Participants
2 Participants
n=9 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Asian
1 Participants
n=9 Participants
1 Participants
n=6 Participants
2 Participants
n=9 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Black or African American
7 Participants
n=9 Participants
3 Participants
n=6 Participants
10 Participants
n=9 Participants
Race (NIH/OMB)
White
4 Participants
n=9 Participants
4 Participants
n=6 Participants
8 Participants
n=9 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=9 Participants
1 Participants
n=6 Participants
3 Participants
n=9 Participants
Region of Enrollment
United States
14 participants
n=9 Participants
9 participants
n=6 Participants
23 participants
n=9 Participants

PRIMARY outcome

Timeframe: Baseline up to 3 months after study start

Weight stability will be documented as percent weight change at 3 months compared to baseline.

Outcome measures

Outcome measures
Measure
Group 2 (gemcitabine/nab-paclitaxel)
n=8 Participants
Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy
Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)
n=14 Participants
Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy Telotristat Ethyl: Given PO
Weight Stability
-5.58 Percent weight change
Standard Deviation 5.89
-1.98 Percent weight change
Standard Deviation 6.87

SECONDARY outcome

Timeframe: Baseline up to 4 months after study start

The change will be summarized as mean and standard deviation.

Outcome measures

Outcome measures
Measure
Group 2 (gemcitabine/nab-paclitaxel)
n=5 Participants
Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy
Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)
n=10 Participants
Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy Telotristat Ethyl: Given PO
Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels
Screening
4 Milligrams
Standard Deviation 46.25
3 Milligrams
Standard Deviation 261.67
Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels
Cycle 1 Day 1 (Treatment day 0)
3 Milligrams
Standard Deviation 44.87
8 Milligrams
Standard Deviation 232.38
Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels
Cycle 2 Day 1 (Treatment day 28)
2 Milligrams
Standard Deviation 144.00
8 Milligrams
Standard Deviation 58.63
Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels
Cycle 3 Day 1 (Treatment day 56)
1 Milligrams
Standard Deviation 273.00
7 Milligrams
Standard Deviation 119.10
Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels
Cycle 4 Day 1 (Treatment day 84)
1 Milligrams
Standard Deviation 10.00
9 Milligrams
Standard Deviation 91.56

SECONDARY outcome

Timeframe: Up to 2 years after study start

Population: This OC was not collected at the following timepoints, and a protocol amendment did not occur. Cycle 7 Day 1, Group 2 Cycle 8 Day 1, Group 2 Cycle 10 Day 1, Group 1 Cycle 11 Day 1, Group 1 Cycle 12 Day 1, Group 1 Cycle 13 Day 1, Group 1 Cycle 14 Day 1, Group 1 Cycle 15 Day 1, Group 1 \& 2 Cycle 17 Day 1, Group 1 \&2 Cycle 18 Day 1 Group 2 Cycle 19 Day 1, Group 2 Cycle 22 Day 1, Group 2 Cycle 23 Day 1, Group 2

Mid arm circumference (MAC) will be reviewed on cross sectional imaging and will be assessed with imaging guided measurements of the psoas and rectus abdominis muscle.

Outcome measures

Outcome measures
Measure
Group 2 (gemcitabine/nab-paclitaxel)
n=5 Participants
Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy
Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)
n=14 Participants
Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy Telotristat Ethyl: Given PO
Mid Arm Circumference (MAC) Measured in cm
Cycle 9 Day 1
29 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
25.4 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
Mid Arm Circumference (MAC) Measured in cm
Cycle 10 Day 1
30 cm
Standard Deviation 0
—
Mid Arm Circumference (MAC) Measured in cm
Cycle 11 Day 1
30 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
—
Mid Arm Circumference (MAC) Measured in cm
Cycle 12 Day 1
30 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
—
Mid Arm Circumference (MAC) Measured in cm
Cycle 13 Day 1
26 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
—
Mid Arm Circumference (MAC) Measured in cm
Cycle 14 Day 1
24 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
—
Mid Arm Circumference (MAC) Measured in cm
Cycle 16 Day 1
—
29.21 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
Mid Arm Circumference (MAC) Measured in cm
Cycle 18 Day 1
—
23 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
Mid Arm Circumference (MAC) Measured in cm
Cycle 19 Day 1
—
25 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
Mid Arm Circumference (MAC) Measured in cm
Cycle 20 Day 1
—
23 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
Mid Arm Circumference (MAC) Measured in cm
Cycle 21 Day 1
24.5 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
26 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
Mid Arm Circumference (MAC) Measured in cm
Cycle 22 Day 1
—
25 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
Mid Arm Circumference (MAC) Measured in cm
Cycle 23 Day 1
—
28.5 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
Mid Arm Circumference (MAC) Measured in cm
Cycle 5 Day 1
31.5 cm
Standard Deviation 0.71
24.81 cm
Standard Deviation 3.52
Mid Arm Circumference (MAC) Measured in cm
Cycle 6 Day 1
31 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
26.67 cm
Standard Deviation 6.24
Mid Arm Circumference (MAC) Measured in cm
Cycle 7 Day 1
—
27.81 cm
Standard Deviation 4.52
Mid Arm Circumference (MAC) Measured in cm
Cycle 8 Day 1
—
21.81 cm
Standard Deviation 8.59
Mid Arm Circumference (MAC) Measured in cm
Screening
34.88 cm
Standard Deviation 6.17
24.35 cm
Standard Deviation 9.43
Mid Arm Circumference (MAC) Measured in cm
Cycle 1 Day 1
35.88 cm
Standard Deviation 5.86
24.39 cm
Standard Deviation 8.69
Mid Arm Circumference (MAC) Measured in cm
Cycle 2 Day 1
35.5 cm
Standard Deviation 5.89
23.98 cm
Standard Deviation 7.28
Mid Arm Circumference (MAC) Measured in cm
Cycle 3 Day 1
27 cm
Standard Deviation NA
Only 1 participant analyzed. SD is NA.
25.71 cm
Standard Deviation 6.12
Mid Arm Circumference (MAC) Measured in cm
Cycle 4 Day 1
29 cm
Standard Deviation 7.07
25.71 cm
Standard Deviation 6.52

SECONDARY outcome

Timeframe: Up to 2 years after study start

Quality of life (QOL) will be assessed by the Obesity Related Quality of Life (OWL-QOL)-17 questionnaire. \*Please note OC Measure was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years after study start

Blood serotonin levels will be compared in the 2 groups.

Outcome measures

Outcome measures
Measure
Group 2 (gemcitabine/nab-paclitaxel)
n=8 Participants
Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy
Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)
n=14 Participants
Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy Telotristat Ethyl: Given PO
Blood Serotonin Levels
Screening
294.67 ng/mL
Interval 213.97 to 375.37
170.92 ng/mL
Interval 121.02 to 220.82
Blood Serotonin Levels
Cycle 1 Day 1 (Treatment day 0
201.33 ng/mL
Interval 191.89 to 228.77
152.75 ng/mL
Interval 106.58 to 198.92
Blood Serotonin Levels
Cycle 2 Day 1 (Treatment day 28)
217 ng/mL
Interval 183.48 to 250.52
96.09 ng/mL
Interval 56.73 to 135.45
Blood Serotonin Levels
Cycle 3 Day 1 (Treatment day 56)
112.67 ng/mL
Interval 34.29 to 191.05
97.67 ng/mL
Interval 54.05 to 141.29
Blood Serotonin Levels
Cycle 4 Day 1 (Treatment day 84)
265 ng/mL
Interval 0.0 to 1531.81
85.33 ng/mL
Interval 53.51 to 117.15

SECONDARY outcome

Timeframe: Up to 2 years after study start

Response rate (RR) will be assessed per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, in patients receiving telotristat ethyl (Group 1).

Outcome measures

Outcome measures
Measure
Group 2 (gemcitabine/nab-paclitaxel)
n=6 Participants
Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy
Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)
n=12 Participants
Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy Telotristat Ethyl: Given PO
Response Rate (RR)
6 Participants
11 Participants

SECONDARY outcome

Timeframe: Up to 2 years after study start

Median overall survival (MOS) will be measured using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure
Group 2 (gemcitabine/nab-paclitaxel)
n=8 Participants
Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy
Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)
n=14 Participants
Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy Telotristat Ethyl: Given PO
Median Overall Survival (MOS)
12.2 Days
Interval 6.1 to 21.4
10.7 Days
Interval 5.4 to 16.9

SECONDARY outcome

Timeframe: Up to 2 years after study start

Duration of response will be estimated from time of documentation of response to time of progression and will be evaluated by computed tomography/magnetic resonance imaging scans of the organ(s) with the target lesion(s) based on RECIST criteria.

Outcome measures

Outcome measures
Measure
Group 2 (gemcitabine/nab-paclitaxel)
n=6 Participants
Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy
Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)
n=9 Participants
Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy Telotristat Ethyl: Given PO
Duration of Response
97 Days
Interval 60.0 to
Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.
94 Days
Interval 9.0 to 172.0

Adverse Events

Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)

Serious events: 2 serious events
Other events: 13 other events
Deaths: 9 deaths

Group 2 (gemcitabine/nab-paclitaxel)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure
Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)
n=14 participants at risk
Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy Telotristat Ethyl: Given PO
Group 2 (gemcitabine/nab-paclitaxel)
n=8 participants at risk
Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy
Respiratory, thoracic and mediastinal disorders
Hospitalization
7.1%
1/14 • Number of events 1 • Up to 2 years
0.00%
0/8 • Up to 2 years
Gastrointestinal disorders
Gastrointestinal disorders
7.1%
1/14 • Number of events 1 • Up to 2 years
0.00%
0/8 • Up to 2 years

Other adverse events

Other adverse events
Measure
Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)
n=14 participants at risk
Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy Telotristat Ethyl: Given PO
Group 2 (gemcitabine/nab-paclitaxel)
n=8 participants at risk
Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given gemcitabine/nab-paclitaxel combination therapy Nab-paclitaxel: Given gemcitabine/nab-paclitaxel combination therapy
Blood and lymphatic system disorders
Blood and lymphatic system disorders
21.4%
3/14 • Number of events 24 • Up to 2 years
37.5%
3/8 • Number of events 3 • Up to 2 years
Gastrointestinal disorders
Gastrointestinal disorders
57.1%
8/14 • Number of events 17 • Up to 2 years
12.5%
1/8 • Number of events 1 • Up to 2 years
General disorders
General disorders and administration site conditions
64.3%
9/14 • Number of events 20 • Up to 2 years
12.5%
1/8 • Number of events 11 • Up to 2 years
Infections and infestations
Infections and infestations
0.00%
0/14 • Up to 2 years
12.5%
1/8 • Number of events 2 • Up to 2 years
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
7.1%
1/14 • Number of events 1 • Up to 2 years
0.00%
0/8 • Up to 2 years
Investigations
Investigations
28.6%
4/14 • Number of events 52 • Up to 2 years
0.00%
0/8 • Up to 2 years
Metabolism and nutrition disorders
Metabolism and nutrition disorders
35.7%
5/14 • Number of events 23 • Up to 2 years
0.00%
0/8 • Up to 2 years
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
7.1%
1/14 • Number of events 1 • Up to 2 years
0.00%
0/8 • Up to 2 years
Nervous system disorders
Nervous system disorders
28.6%
4/14 • Number of events 9 • Up to 2 years
12.5%
1/8 • Number of events 1 • Up to 2 years
Psychiatric disorders
Psychiatric disorders
14.3%
2/14 • Number of events 3 • Up to 2 years
0.00%
0/8 • Up to 2 years
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
14.3%
2/14 • Number of events 3 • Up to 2 years
0.00%
0/8 • Up to 2 years
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
28.6%
4/14 • Number of events 5 • Up to 2 years
0.00%
0/8 • Up to 2 years
Vascular disorders
Vascular disorders
14.3%
2/14 • Number of events 4 • Up to 2 years
0.00%
0/8 • Up to 2 years

Additional Information

Dr. Olumide Gbolahan

Emory University

Phone: 404-778-1900

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place