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Trial Outcomes & Findings for Sitagliptin Umbilical Cord Blood Transplant Study (NCT NCT00862719)

NCT ID: NCT00862719

Last Updated: 2016-10-07

Results Overview

Evaluate the efficacy of CD26/DPP-IV inhibition in increasing the cumulative incidence of adult patients with hematological malignancies engrafting by day +30 following transplantation of UCB by 30 percent. The cumulative incidence of patients achieving this will be reported. The value of the estimate will be from bootstrapping 1000 samples with replacement of the data and the 95% confidence interval will be calculated using the percentile method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

Transplant (Day 0) through Day +30

Results posted on

2016-10-07

Participant Flow

Initially based on single arm 2 stage design using 600 mg sitagliptin/24 hrs in RBC replete and RBC depleted UCB units. In an unplanned interim analysis after 1st 20 enrolled pts, protocol was amended to exclude RBC replete UCB units due to worse outcomes and to test more frequent dosing of sitagliptin due to suboptimal inhibition of plasma DPP-IV.

Participant milestones

Participant milestones
Measure
Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
600 mg Sitagliptin/12 Hrs
600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
600 mg Sitagliptin/8 Hrs
600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
Overall Study
STARTED
17
7
4
1
Overall Study
COMPLETED
7
1
0
0
Overall Study
NOT COMPLETED
10
6
4
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
600 mg Sitagliptin/12 Hrs
600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
600 mg Sitagliptin/8 Hrs
600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
Overall Study
Disease Progression
5
0
1
0
Overall Study
Death
5
6
1
1
Overall Study
Engraftment failure
0
0
1
0
Overall Study
Veno-Occlusive Disease
0
0
1
0

Baseline Characteristics

Sitagliptin Umbilical Cord Blood Transplant Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs
n=17 Participants
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24
n=7 Participants
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
600 mg Sitagliptin/12 Hrs
n=4 Participants
600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
600 mg Sitagliptin/8 Hrs
n=1 Participants
600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
Total
n=29 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Age, Categorical
Between 18 and 65 years
17 Participants
n=5 Participants
7 Participants
n=7 Participants
4 Participants
n=5 Participants
1 Participants
n=4 Participants
29 Participants
n=21 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Age, Continuous
40.6 years
STANDARD_DEVIATION 10.86 • n=5 Participants
34.8 years
STANDARD_DEVIATION 8.95 • n=7 Participants
46.9 years
STANDARD_DEVIATION 7.94 • n=5 Participants
54.9 years
STANDARD_DEVIATION 0 • n=4 Participants
40.6 years
STANDARD_DEVIATION 10.62 • n=21 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
4 Participants
n=7 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
19 Participants
n=21 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
3 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
10 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
n=5 Participants
7 Participants
n=7 Participants
4 Participants
n=5 Participants
1 Participants
n=4 Participants
29 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
5 Participants
n=21 Participants
Race (NIH/OMB)
White
14 Participants
n=5 Participants
5 Participants
n=7 Participants
4 Participants
n=5 Participants
1 Participants
n=4 Participants
24 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants

PRIMARY outcome

Timeframe: Transplant (Day 0) through Day +30

Population: Modified Intent to treat population (mITT) - all patients receiving at least one dose of study drug and receiving REB depleted UCB units only

Evaluate the efficacy of CD26/DPP-IV inhibition in increasing the cumulative incidence of adult patients with hematological malignancies engrafting by day +30 following transplantation of UCB by 30 percent. The cumulative incidence of patients achieving this will be reported. The value of the estimate will be from bootstrapping 1000 samples with replacement of the data and the 95% confidence interval will be calculated using the percentile method.

Outcome measures

Outcome measures
Measure
Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs
n=17 Participants
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
600 mg Sitagliptin/12 Hrs
600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
600 mg Sitagliptin/8 Hrs
600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
Cumulative Incidence of Patients With Engraftment by Day +30 Following Transplant
88 percentage of participants
Interval 74.0 to 100.0
—
—
—

SECONDARY outcome

Timeframe: Transplant (Day 0) up to 1 year

Population: All patients enrolled and received treatment.

Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided. For the RCD group, all patients engrafted before day +30, except one patient who died at day 28 before engraftment. For the PD group, all patients engrafted before day +100, except one patient who died on day +103 before engraftment. For the 600 mg sitagliptin/12 hours group, two patients engrafted before day +100, and the other two patients died before day +100 before engraftment. The one patient on 600 mg sitagliptin/8 hours died on day +14 before engraftment.

Outcome measures

Outcome measures
Measure
Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs
n=17 Participants
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24
n=7 Participants
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
600 mg Sitagliptin/12 Hrs
n=4 Participants
600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
600 mg Sitagliptin/8 Hrs
n=1 Participants
600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
Time to Neutrophil Engraftment
21 days
Interval 15.0 to 25.0
35 days
Interval 25.0 to 98.0
51 days
Interval 23.0 to 95.0
14 days
Only 1 patient was in this group and so a 95% Confidence Interval was not able to be calculated.

SECONDARY outcome

Timeframe: Transplant (Day 0) up to 1 year

Population: All patients enrolled and received treatment who achieved platelet recovery/engraftment of platelets.

Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.

Outcome measures

Outcome measures
Measure
Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs
n=17 Participants
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24
n=7 Participants
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
600 mg Sitagliptin/12 Hrs
n=4 Participants
600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
600 mg Sitagliptin/8 Hrs
n=1 Participants
600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
Time to Platelet Engraftment
77 days
Interval 51.0 to 97.0
91 days
Interval 80.0 to 102.0
NA days
With few patients, the median was not able to be achieved and the 95% confidence interval could not be calculated.
NA days
With few patients, the median was not able to be achieved and the 95% confidence interval could not be calculated.

SECONDARY outcome

Timeframe: Transplant (Day 0) up to 3 years

Population: All patients enrolled and received treatment.

Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.

Outcome measures

Outcome measures
Measure
Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs
n=17 Participants
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24
n=7 Participants
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
600 mg Sitagliptin/12 Hrs
n=4 Participants
600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
600 mg Sitagliptin/8 Hrs
n=1 Participants
600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
Treatment Related Adverse Events Grade 3 or Higher for Non-hematological Toxicity
0 participants
0 participants
0 participants
1 participants

Adverse Events

Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs

Serious events: 11 serious events
Other events: 17 other events
Deaths: 0 deaths

Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24

Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths

600 mg Sitagliptin/12 Hrs

Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths

600 mg Sitagliptin/8 Hrs

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs
n=17 participants at risk
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24
n=7 participants at risk
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
600 mg Sitagliptin/12 Hrs
n=4 participants at risk
600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
600 mg Sitagliptin/8 Hrs
n=1 participants at risk
600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
Blood and lymphatic system disorders
BLOOD/BONE MARROW - OTHER
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Blood and lymphatic system disorders
LYMPHATICS - OTHER
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Cardiac disorders
CARDIAC GENERAL - OTHER
0.00%
0/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
100.0%
1/1 • up to 3 years
Cardiac disorders
RESTRICTIVE CARDIOMYOPATHY
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
DIARRHEA
23.5%
4/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
NAUSEA
17.6%
3/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
PAIN - ABDOMEN NOS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
VOMITING
17.6%
3/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
General disorders
HYPOTHERMIA
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Hepatobiliary disorders
HEPATOBILIARY/PANCREAS - OTHER
0.00%
0/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Hepatobiliary disorders
LIVER DYSFUNCTION/FAILURE (CLINICAL)
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
100.0%
1/1 • up to 3 years
Infections and infestations
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
23.5%
4/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION - OTHER
23.5%
4/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BRONCHUS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
5.9%
1/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - SINUS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Investigations
CERVICAL SPINE-RANGE OF MOTION
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
PAIN - EXTREMITY-LIMB
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
CONFUSION
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
PAIN - HEAD/HEADACHE
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Renal and urinary disorders
RENAL FAILURE
0.00%
0/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
ADULT RESPIRATORY DISTRESS SYNDROME (ARDS)
0.00%
0/17 • up to 3 years
42.9%
3/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
EDEMA, LARYNX
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
HYPOXIA
29.4%
5/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
100.0%
1/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
0.00%
0/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
11.8%
2/17 • up to 3 years
28.6%
2/7 • up to 3 years
0.00%
0/4 • up to 3 years
100.0%
1/1 • up to 3 years
Vascular disorders
HEMORRHAGE, GI - ABDOMEN NOS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE, GI - LOWER GI NOS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE, GU - URINARY NOS
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - LUNG
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - RESPIRATORY TRACT NOS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HYPOTENSION
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
100.0%
1/1 • up to 3 years
Vascular disorders
VASCULAR - OTHER
0.00%
0/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
100.0%
1/1 • up to 3 years

Other adverse events

Other adverse events
Measure
Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs
n=17 participants at risk
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24
n=7 participants at risk
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
600 mg Sitagliptin/12 Hrs
n=4 participants at risk
600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
600 mg Sitagliptin/8 Hrs
n=1 participants at risk
600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
Blood and lymphatic system disorders
BLOOD/BONE MARROW - OTHER
5.9%
1/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Blood and lymphatic system disorders
COAGULATION - OTHER
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Blood and lymphatic system disorders
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
11.8%
2/17 • up to 3 years
28.6%
2/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Blood and lymphatic system disorders
LYMPHATICS - OTHER
17.6%
3/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER
29.4%
5/17 • up to 3 years
57.1%
4/7 • up to 3 years
25.0%
1/4 • up to 3 years
100.0%
1/1 • up to 3 years
Cardiac disorders
CARDIAC GENERAL - OTHER
17.6%
3/17 • up to 3 years
42.9%
3/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Cardiac disorders
PERICARDIAL EFFUSION (NON-MALIGNANT)
17.6%
3/17 • up to 3 years
28.6%
2/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Cardiac disorders
RESTRICTIVE CARDIOMYOPATHY
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA
41.2%
7/17 • up to 3 years
28.6%
2/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Cardiac disorders
VALVULAR HEART DISEASE
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Cardiac disorders
VENTRICULAR ARRHYTHMIA - VENTRICULAR TACHYCARDIA
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Ear and labyrinth disorders
AUDITORY/EAR - OTHER
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Ear and labyrinth disorders
PAIN - MIDDLE EAR
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Endocrine disorders
THYROID FUNCTION, LOW (HYPOTHYROIDISM)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Eye disorders
DRY EYE SYNDROME
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Eye disorders
OPHTHALMOPLEGIA/DIPLOPIA (DOUBLE VISION)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Eye disorders
PAIN - EYE
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Eye disorders
RETINAL DETACHMENT
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Eye disorders
VISION-BLURRED VISION
17.6%
3/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Eye disorders
VISION-FLASHING LIGHTS/FLOATERS
5.9%
1/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Eye disorders
WATERY EYE (EPIPHORA, TEARING)
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
ASCITES (NON-MALIGNANT)
23.5%
4/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
COLITIS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
COLITIS, INFECTIOUS (E.G., CLOSTRIDIUM DIFFICILE)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
CONSTIPATION
23.5%
4/17 • up to 3 years
42.9%
3/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
DIARRHEA
100.0%
17/17 • up to 3 years
100.0%
7/7 • up to 3 years
100.0%
4/4 • up to 3 years
100.0%
1/1 • up to 3 years
Gastrointestinal disorders
DISTENSION/BLOATING, ABDOMINAL
23.5%
4/17 • up to 3 years
14.3%
1/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
5.9%
1/17 • up to 3 years
28.6%
2/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
FLATULENCE
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
GASTROINTESTINAL - OTHER
17.6%
3/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
HEMORRHOIDS
5.9%
1/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
HICCOUGHS (HICCUPS, SINGULTUS)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
INCONTINENCE, ANAL
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ESOPHAGUS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY
88.2%
15/17 • up to 3 years
100.0%
7/7 • up to 3 years
75.0%
3/4 • up to 3 years
100.0%
1/1 • up to 3 years
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY
5.9%
1/17 • up to 3 years
14.3%
1/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
NAUSEA
88.2%
15/17 • up to 3 years
71.4%
5/7 • up to 3 years
100.0%
4/4 • up to 3 years
100.0%
1/1 • up to 3 years
Gastrointestinal disorders
OBSTRUCTION, GI - STOMACH
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
OCULAR/VISUAL - OTHER
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
PAIN - ABDOMEN NOS
76.5%
13/17 • up to 3 years
42.9%
3/7 • up to 3 years
75.0%
3/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
PAIN - ANUS
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
PAIN - DENTAL/TEETH/PERIDONTAL
0.00%
0/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
PAIN - RECTUM
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Gastrointestinal disorders
VOMITING
82.4%
14/17 • up to 3 years
85.7%
6/7 • up to 3 years
100.0%
4/4 • up to 3 years
0.00%
0/1 • up to 3 years
General disorders
EDEMA: HEAD AND NECK
17.6%
3/17 • up to 3 years
14.3%
1/7 • up to 3 years
25.0%
1/4 • up to 3 years
100.0%
1/1 • up to 3 years
General disorders
EDEMA: LIMB
70.6%
12/17 • up to 3 years
57.1%
4/7 • up to 3 years
50.0%
2/4 • up to 3 years
100.0%
1/1 • up to 3 years
General disorders
EDEMA: TRUNK/GENITAL
29.4%
5/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
General disorders
EDEMA: VISCERA
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
11.8%
2/17 • up to 3 years
42.9%
3/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
82.4%
14/17 • up to 3 years
57.1%
4/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
General disorders
PAIN - BUTTOCK
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
General disorders
PAIN - CHEST WALL
11.8%
2/17 • up to 3 years
28.6%
2/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
General disorders
PAIN - CHEST/THORAX NOS
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
General disorders
PAIN - OTHER
64.7%
11/17 • up to 3 years
42.9%
3/7 • up to 3 years
25.0%
1/4 • up to 3 years
100.0%
1/1 • up to 3 years
General disorders
PAIN - PAIN NOS
17.6%
3/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
General disorders
RIGORS/CHILLS
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
General disorders
SWEATING (DIAPHORESIS)
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Hepatobiliary disorders
CHOLECYSTITIS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Hepatobiliary disorders
HEPATOBILIARY/PANCREAS - OTHER
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Hepatobiliary disorders
LIVER DYSFUNCTION/FAILURE (CLINICAL)
5.9%
1/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Immune system disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
41.2%
7/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Immune system disorders
ALLERGY/IMMUNOLOGY - OTHER
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Immune system disorders
SERUM SICKNESS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
76.5%
13/17 • up to 3 years
71.4%
5/7 • up to 3 years
75.0%
3/4 • up to 3 years
100.0%
1/1 • up to 3 years
Infections and infestations
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
64.7%
11/17 • up to 3 years
57.1%
4/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION - OTHER
64.7%
11/17 • up to 3 years
57.1%
4/7 • up to 3 years
75.0%
3/4 • up to 3 years
100.0%
1/1 • up to 3 years
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - ANAL/PERIANAL
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY)
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - COLON
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - PARANASAL
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SMALL BOWEL NOS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS
17.6%
3/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - BLADDER (URINARY)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - BLOOD
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - COLON
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - CONJUNCTIVA
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - EYE NOS
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
11.8%
2/17 • up to 3 years
28.6%
2/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - MIDDLE EAR (OTITIS MEDIA)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - SINUS
35.3%
6/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - SKIN (CELLULITIS)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - SOFT TISSUE NOS
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS
17.6%
3/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Infections and infestations
INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Injury, poisoning and procedural complications
WOUND COMPLICATION, NON-INFECTIOUS
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Investigations
ALKALINE PHOSPHATASE
88.2%
15/17 • up to 3 years
57.1%
4/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
100.0%
17/17 • up to 3 years
57.1%
4/7 • up to 3 years
75.0%
3/4 • up to 3 years
100.0%
1/1 • up to 3 years
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
100.0%
17/17 • up to 3 years
85.7%
6/7 • up to 3 years
100.0%
4/4 • up to 3 years
100.0%
1/1 • up to 3 years
Investigations
BICARBONATE, SERUM-LOW
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Investigations
CARDIAC TROPONIN I (CTNI)
0.00%
0/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
100.0%
1/1 • up to 3 years
Investigations
CREATININE
70.6%
12/17 • up to 3 years
71.4%
5/7 • up to 3 years
75.0%
3/4 • up to 3 years
100.0%
1/1 • up to 3 years
Investigations
HAPTOGLOBIN
0.00%
0/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Investigations
HEMOGLOBIN
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Investigations
ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION)
0.00%
0/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Investigations
METABOLIC/LABORATORY - OTHER
29.4%
5/17 • up to 3 years
14.3%
1/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
Investigations
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Investigations
PLATELETS
5.9%
1/17 • up to 3 years
28.6%
2/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Investigations
PROLONGED QTC INTERVAL
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Investigations
WEIGHT GAIN
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
Investigations
WEIGHT LOSS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Metabolism and nutrition disorders
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
64.7%
11/17 • up to 3 years
57.1%
4/7 • up to 3 years
75.0%
3/4 • up to 3 years
100.0%
1/1 • up to 3 years
Metabolism and nutrition disorders
ANOREXIA
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Metabolism and nutrition disorders
BILIRUBIN (HYPERBILIRUBINEMIA)
88.2%
15/17 • up to 3 years
85.7%
6/7 • up to 3 years
50.0%
2/4 • up to 3 years
100.0%
1/1 • up to 3 years
Metabolism and nutrition disorders
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
47.1%
8/17 • up to 3 years
42.9%
3/7 • up to 3 years
75.0%
3/4 • up to 3 years
0.00%
0/1 • up to 3 years
Metabolism and nutrition disorders
DEHYDRATION
17.6%
3/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Metabolism and nutrition disorders
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
58.8%
10/17 • up to 3 years
42.9%
3/7 • up to 3 years
75.0%
3/4 • up to 3 years
0.00%
0/1 • up to 3 years
Metabolism and nutrition disorders
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Metabolism and nutrition disorders
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
41.2%
7/17 • up to 3 years
42.9%
3/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
Metabolism and nutrition disorders
PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
41.2%
7/17 • up to 3 years
57.1%
4/7 • up to 3 years
75.0%
3/4 • up to 3 years
0.00%
0/1 • up to 3 years
Metabolism and nutrition disorders
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Metabolism and nutrition disorders
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
29.4%
5/17 • up to 3 years
71.4%
5/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
Metabolism and nutrition disorders
SODIUM, SERUM-HIGH (HYPERNATREMIA)
23.5%
4/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Metabolism and nutrition disorders
SODIUM, SERUM-LOW (HYPONATREMIA)
35.3%
6/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Metabolism and nutrition disorders
TRIGLYCERIDE, SERUM-HIGH (HYPERTRIGLYCERIDEMIA)
17.6%
3/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
FRACTURE
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-UPPER
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - WHOLE BODY/GENERALIZED
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE - OTHER
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
PAIN - BACK
47.1%
8/17 • up to 3 years
14.3%
1/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
PAIN - BONE
35.3%
6/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
PAIN - EXTREMITY-LIMB
29.4%
5/17 • up to 3 years
14.3%
1/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
PAIN - JOINT
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
PAIN - MUSCLE
11.8%
2/17 • up to 3 years
28.6%
2/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
PAIN - NECK
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Musculoskeletal and connective tissue disorders
SOFT TISSUE NECROSIS - EXTREMITY-LOWER
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
CONFUSION
41.2%
7/17 • up to 3 years
42.9%
3/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
DIZZINESS
29.4%
5/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
100.0%
1/1 • up to 3 years
Nervous system disorders
ENCEPHALOPATHY
17.6%
3/17 • up to 3 years
28.6%
2/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
MEMORY IMPAIRMENT
0.00%
0/17 • up to 3 years
28.6%
2/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
MOOD ALTERATION - AGITATION
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
MOOD ALTERATION - ANXIETY
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
MOOD ALTERATION - DEPRESSION
23.5%
4/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
NEUROLOGY - OTHER
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
NEUROPATHY: MOTOR
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
NEUROPATHY: SENSORY
41.2%
7/17 • up to 3 years
14.3%
1/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
PAIN - HEAD/HEADACHE
52.9%
9/17 • up to 3 years
57.1%
4/7 • up to 3 years
25.0%
1/4 • up to 3 years
100.0%
1/1 • up to 3 years
Nervous system disorders
PAIN - NEURALGIA/PERIPHERAL NERVE
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
SEIZURE
5.9%
1/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
SYNCOPE (FAINTING)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Nervous system disorders
TREMOR
23.5%
4/17 • up to 3 years
57.1%
4/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Psychiatric disorders
INSOMNIA
17.6%
3/17 • up to 3 years
42.9%
3/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Psychiatric disorders
PSYCHOSIS (HALLUCINATIONS/DELUSIONS)
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Renal and urinary disorders
BLADDER SPASMS
35.3%
6/17 • up to 3 years
28.6%
2/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Renal and urinary disorders
CYSTITIS
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Renal and urinary disorders
INCONTINENCE, URINARY
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Renal and urinary disorders
PAIN - BLADDER
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Renal and urinary disorders
RENAL FAILURE
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
50.0%
2/4 • up to 3 years
100.0%
1/1 • up to 3 years
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER
5.9%
1/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
100.0%
1/1 • up to 3 years
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Renal and urinary disorders
URINE COLOR CHANGE
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Reproductive system and breast disorders
IRREGULAR MENSES (CHANGE FROM BASELINE)
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Reproductive system and breast disorders
PAIN - PELVIS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Reproductive system and breast disorders
PAIN - URETHRA
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Reproductive system and breast disorders
PAIN - VAGINA
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Reproductive system and breast disorders
VAGINAL DISCHARGE (NON-INFECTIOUS)
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Reproductive system and breast disorders
VAGINAL DRYNESS
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
PAIN - THROAT/PHARYNX/LARYNX
23.5%
4/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
ADULT RESPIRATORY DISTRESS SYNDROME (ARDS)
5.9%
1/17 • up to 3 years
14.3%
1/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM, WHEEZING
5.9%
1/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
COUGH
47.1%
8/17 • up to 3 years
57.1%
4/7 • up to 3 years
0.00%
0/4 • up to 3 years
100.0%
1/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
47.1%
8/17 • up to 3 years
42.9%
3/7 • up to 3 years
75.0%
3/4 • up to 3 years
0.00%
0/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
EDEMA, LARYNX
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
HYPOXIA
64.7%
11/17 • up to 3 years
57.1%
4/7 • up to 3 years
25.0%
1/4 • up to 3 years
100.0%
1/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
NASAL CAVITY/PARANASAL SINUS REACTIONS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
41.2%
7/17 • up to 3 years
14.3%
1/7 • up to 3 years
25.0%
1/4 • up to 3 years
100.0%
1/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
23.5%
4/17 • up to 3 years
28.6%
2/7 • up to 3 years
25.0%
1/4 • up to 3 years
100.0%
1/1 • up to 3 years
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
5.9%
1/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER
29.4%
5/17 • up to 3 years
28.6%
2/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
Skin and subcutaneous tissue disorders
DRY SKIN
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Skin and subcutaneous tissue disorders
PAIN - SKIN
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
35.3%
6/17 • up to 3 years
14.3%
1/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
35.3%
6/17 • up to 3 years
42.9%
3/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
41.2%
7/17 • up to 3 years
0.00%
0/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
Skin and subcutaneous tissue disorders
RASH: DERMATITIS ASSOCIATED WITH RADIATION - RADIATION
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Skin and subcutaneous tissue disorders
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Skin and subcutaneous tissue disorders
SKIN BREAKDOWN/DECUBITUS ULCER
5.9%
1/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Skin and subcutaneous tissue disorders
ULCERATION
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE, CNS
0.00%
0/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
100.0%
1/1 • up to 3 years
Vascular disorders
HEMORRHAGE, GI - ABDOMEN NOS
23.5%
4/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE, GI - ANUS
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE, GI - LOWER GI NOS
11.8%
2/17 • up to 3 years
14.3%
1/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE, GI - UPPER GI NOS
5.9%
1/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE, GU - BLADDER
23.5%
4/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE, GU - URINARY NOS
29.4%
5/17 • up to 3 years
42.9%
3/7 • up to 3 years
50.0%
2/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE, GU - VAGINA
23.5%
4/17 • up to 3 years
28.6%
2/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - BRONCHOPULMONARY NOS
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE
29.4%
5/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HEMORRHAGE/BLEEDING - OTHER
0.00%
0/17 • up to 3 years
14.3%
1/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HYPERTENSION
35.3%
6/17 • up to 3 years
28.6%
2/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
HYPOTENSION
52.9%
9/17 • up to 3 years
42.9%
3/7 • up to 3 years
75.0%
3/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
PERIPHERAL ARTERIAL ISCHEMIA
0.00%
0/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
100.0%
1/1 • up to 3 years
Vascular disorders
PULMONARY HYPERTENSION
5.9%
1/17 • up to 3 years
0.00%
0/7 • up to 3 years
0.00%
0/4 • up to 3 years
0.00%
0/1 • up to 3 years
Vascular disorders
VASCULAR - OTHER
11.8%
2/17 • up to 3 years
0.00%
0/7 • up to 3 years
25.0%
1/4 • up to 3 years
0.00%
0/1 • up to 3 years

Additional Information

Dr. Sherif Farag

IndianaU

Phone: 317-944-0920

Results disclosure agreements

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