Trial Outcomes & Findings for APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer (NCT NCT00709826)

NCT ID: NCT00709826

Last Updated: 2012-11-07

Results Overview

Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 109 participants
• Primary outcome timeframe: Randomization then every other cycle
• Results posted on: 2012-11-07

Participant Flow

Study opened to accrual in August 2008. Enrollment closed on November 2010. One hundred and nine patients were randomized. Patients were recruited from clinical oncology practices.

Participant milestones

Measure	Apricoxib/Gemcitabine/Erlotinib Patients randomized to receive apricoxib + gemcitabine + erlotinib.	Placebo/Gemcitabine/Erlotinib Patients randomized to receive placebo + gemcitabine + erlotinib.
Overall Study STARTED	70	39
Overall Study COMPLETED	68	38
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer

Baseline characteristics by cohort

Measure	Apricoxib/Gemcitabine/Erlotinib n=70 Participants Patients randomized to receive apricoxib + gemcitabine + erlotinib.	Placebo/Gemcitabine/Erlotinib n=39 Participants Patients randomized to receive placebo + gemcitabine + erlotinib.	Total n=109 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=93 Participants	17 Participants n=4 Participants	55 Participants n=27 Participants
Age, Categorical >=65 years	32 Participants n=93 Participants	22 Participants n=4 Participants	54 Participants n=27 Participants
Age Continuous	63 years STANDARD_DEVIATION 64.2 • n=93 Participants	67 years STANDARD_DEVIATION 66 • n=4 Participants	64 years STANDARD_DEVIATION 64.8 • n=27 Participants
Sex: Female, Male Female	41 Participants n=93 Participants	22 Participants n=4 Participants	63 Participants n=27 Participants
Sex: Female, Male Male	29 Participants n=93 Participants	17 Participants n=4 Participants	46 Participants n=27 Participants
Region of Enrollment United States	70 participants n=93 Participants	39 participants n=4 Participants	109 participants n=27 Participants

PRIMARY outcome

Timeframe: Randomization then every other cycle

Population: A 1-sided log rank test was used to achieve 80% power at an α=0.20 significance level to detect a difference of 0.16 between the proportions of patients who were progression free in AP/EG (0.35) and P/EG (0.19) after 9 months; an overall sample size of approximately 110 patients (73 in AP/EG and 37 in P/EG) was randomized in a 2:1 ratio.

Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.

Outcome measures

Measure	Apricoxib/Gemcitabine/Erlotinib n=70 Participants Patients randomized to receive apricoxib + gemcitabine + erlotinib.	Placebo/Gemcitabine/Erlotinib n=39 Participants Patients randomized to receive placebo + gemcitabine + erlotinib.
Progression Free Survival	3.0 Months Interval 2.57 to 6.47	2.8 Months Interval 2.63 to 4.6

SECONDARY outcome

Timeframe: Randomization then every other cycle

Outcome measures

Measure	Apricoxib/Gemcitabine/Erlotinib n=70 Participants Patients randomized to receive apricoxib + gemcitabine + erlotinib.	Placebo/Gemcitabine/Erlotinib n=39 Participants Patients randomized to receive placebo + gemcitabine + erlotinib.
Overall Survival	5.0 Months Interval 3.67 to 50.47	4.8 Months Interval 4.07 to 5.7

Adverse Events

Apricoxib/Gemcitabine/Erlotinib

Serious events: 16 serious events

Other events: 70 other events

Deaths: 0 deaths

Placebo/Gemcitabine/Erlotinib

Serious events: 5 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Measure	Apricoxib/Gemcitabine/Erlotinib n=70 participants at risk Patients randomized to receive apricoxib + gemcitabine + erlotinib.	Placebo/Gemcitabine/Erlotinib n=39 participants at risk Patients randomized to receive placebo + gemcitabine + erlotinib.
Blood and lymphatic system disorders Anemia	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Cardiac disorders Myocardial infarction	0.00% 0/70 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	2.6% 1/39 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Duodenal ulcer perforation	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Gastrointestinal hemorrhage	7.1% 5/70 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Nausea	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Esophagitis ulcerative	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Ulcer	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Vomiting	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	2.6% 1/39 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Infections and infestations Pneumocystis jiroveci pneumonia	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Infections and infestations Sepsis	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Investigations International normalized ratio increased	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Metabolism and nutrition disorders Dehydration	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/70 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	2.6% 1/39 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Nervous system disorders Headache	0.00% 0/70 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	2.6% 1/39 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Renal and urinary disorders Renal failure	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Renal and urinary disorders Renal failure acute	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Vascular disorders Cerebrovascular accident	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Vascular disorders Embolic stroke	0.00% 0/70 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	2.6% 1/39 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Vascular disorders Pulmonary embolism	1.4% 1/70 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.

Other adverse events

Measure	Apricoxib/Gemcitabine/Erlotinib n=70 participants at risk Patients randomized to receive apricoxib + gemcitabine + erlotinib.	Placebo/Gemcitabine/Erlotinib n=39 participants at risk Patients randomized to receive placebo + gemcitabine + erlotinib.
Gastrointestinal disorders Diarrhea	58.6% 41/70 • Number of events 41 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	43.6% 17/39 • Number of events 17 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Nausea	58.6% 41/70 • Number of events 41 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	38.5% 15/39 • Number of events 15 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
General disorders Fatigue	57.1% 40/70 • Number of events 40 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	61.5% 24/39 • Number of events 24 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Blood and lymphatic system disorders Anemia	52.9% 37/70 • Number of events 37 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	46.2% 18/39 • Number of events 18 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Skin and subcutaneous tissue disorders Rash	45.7% 32/70 • Number of events 32 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	51.3% 20/39 • Number of events 20 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Blood and lymphatic system disorders Thrombocytopenia	41.4% 29/70 • Number of events 29 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	35.9% 14/39 • Number of events 14 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Constipation	37.1% 26/70 • Number of events 26 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	17.9% 7/39 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Vomiting	32.9% 23/70 • Number of events 23 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	30.8% 12/39 • Number of events 12 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Respiratory, thoracic and mediastinal disorders Dyspnea	31.4% 22/70 • Number of events 22 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	35.9% 14/39 • Number of events 14 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Abdominal pain	30.0% 21/70 • Number of events 21 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	15.4% 6/39 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Blood and lymphatic system disorders Neutropenia	30.0% 21/70 • Number of events 21 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	33.3% 13/39 • Number of events 13 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Musculoskeletal and connective tissue disorders Edema peripheral	30.0% 21/70 • Number of events 21 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	46.2% 18/39 • Number of events 18 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Metabolism and nutrition disorders Anorexia	25.7% 18/70 • Number of events 18 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	15.4% 6/39 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
General disorders Dehydration	24.3% 17/70 • Number of events 17 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	15.4% 6/39 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	21.4% 15/70 • Number of events 15 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	5.1% 2/39 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Mucosal inflammation	17.1% 12/70 • Number of events 12 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	10.3% 4/39 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Psychiatric disorders Insomnia	15.7% 11/70 • Number of events 11 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	12.8% 5/39 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Abdominal distension	14.3% 10/70 • Number of events 10 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	7.7% 3/39 • Number of events 3 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Nervous system disorders Dizziness	14.3% 10/70 • Number of events 10 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	12.8% 5/39 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Metabolism and nutrition disorders Hypokalemia	14.3% 10/70 • Number of events 10 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	15.4% 6/39 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
General disorders Asthenia	12.9% 9/70 • Number of events 9 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	15.4% 6/39 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Dyspepsia	12.9% 9/70 • Number of events 9 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	2.6% 1/39 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
General disorders Chills	11.4% 8/70 • Number of events 8 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	10.3% 4/39 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Respiratory, thoracic and mediastinal disorders Cough	11.4% 8/70 • Number of events 8 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	12.8% 5/39 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Vascular disorders Deep vein thrombosis	11.4% 8/70 • Number of events 8 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	12.8% 5/39 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Gastrointestinal hemorrhage	11.4% 8/70 • Number of events 8 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	2.6% 1/39 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Abdominal pain upper	10.0% 7/70 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	7.7% 3/39 • Number of events 3 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Psychiatric disorders Anxiety	10.0% 7/70 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	7.7% 3/39 • Number of events 3 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Musculoskeletal and connective tissue disorders Back pain	10.0% 7/70 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	7.7% 3/39 • Number of events 3 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Vascular disorders Epistaxis	10.0% 7/70 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	10.3% 4/39 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Vascular disorders Hypotension	10.0% 7/70 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	12.8% 5/39 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Skin and subcutaneous tissue disorders Night sweats	10.0% 7/70 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	2.6% 1/39 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Ascites	8.6% 6/70 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	2.6% 1/39 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Flatulence	8.6% 6/70 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Hepatobiliary disorders Jaundice	8.6% 6/70 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	7.7% 3/39 • Number of events 3 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Infections and infestations Pneumonia	8.6% 6/70 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	5.1% 2/39 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Renal and urinary disorders Renal failure	8.6% 6/70 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	0.00% 0/39 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Investigations Weight decreased	8.6% 6/70 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	10.3% 4/39 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Investigations Alanine aminotransferase increased	7.1% 5/70 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	5.1% 2/39 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Skin and subcutaneous tissue disorders Alopecia	7.1% 5/70 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	10.3% 4/39 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Infections and infestations Cellulitis	7.1% 5/70 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	2.6% 1/39 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Psychiatric disorders Depression	7.1% 5/70 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	12.8% 5/39 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Skin and subcutaneous tissue disorders Dry skin	7.1% 5/70 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	5.1% 2/39 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Nervous system disorders Dysgeusia	7.1% 5/70 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	10.3% 4/39 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Nervous system disorders Headache	7.1% 5/70 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	5.1% 2/39 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Investigations Liver function test abnormal	7.1% 5/70 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	2.6% 1/39 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Skin and subcutaneous tissue disorders Pruritus	7.1% 5/70 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	15.4% 6/39 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
General disorders Pyrexia	7.1% 5/70 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	17.9% 7/39 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Stomatitis	7.1% 5/70 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	2.6% 1/39 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Infections and infestations Upper respiratory tract infection	7.1% 5/70 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	2.6% 1/39 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Investigations Aspartate aminotransferase increased	5.7% 4/70 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	5.1% 2/39 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Metabolism and nutrition disorders Decreased appetite	5.7% 4/70 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	12.8% 5/39 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Skin and subcutaneous tissue disorders Erythema	5.7% 4/70 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	5.1% 2/39 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Gastrointestinal disorders Gastroesophageal reflux disease	5.7% 4/70 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	5.1% 2/39 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Hepatobiliary disorders Hyperbilirubinemia	5.7% 4/70 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	7.7% 3/39 • Number of events 3 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
General disorders Edema	5.7% 4/70 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	5.1% 2/39 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
General disorders Pain	5.7% 4/70 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	7.7% 3/39 • Number of events 3 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Vascular disorders Pulmonary embolism	5.7% 4/70 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	10.3% 4/39 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Infections and infestations Urinary tract infection	5.7% 4/70 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	17.9% 7/39 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Metabolism and nutrition disorders Hypomagnesemia	2.9% 2/70 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	15.4% 6/39 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.
Metabolism and nutrition disorders Hyponatremia	2.9% 2/70 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.	15.4% 6/39 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug Only drug-related serious adverse events are listed.

Additional Information

Tracy Parrott

Tragara Pharmaceuticals

Phone: 760-208-6919

Email: tparrott@tragarapharma.com

Results disclosure agreements

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