Trial Outcomes & Findings for Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors (NCT NCT01121562)

Last Updated: 2014-06-30

Results Overview

CBR rate is defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR) ,or stable disease (SD) ≥ 24 weeks. Based on RECIST, CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. SD is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest dimensions since the treatment started.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Up to 799 days of treatment

Results posted on

2014-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	Sunitinib Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Overall Study STARTED	12
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Sunitinib Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Overall Study Objective progression or relapse	8
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1
Overall Study Sponsor Decision	1
Overall Study Met study discontinuation criteria	1

Baseline Characteristics

Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib n=12 Participants Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Age, Continuous	54.1 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 799 days of treatment

Population: Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Sunitinib n=12 Participants Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Clinical Benefit Response Rate (CBR)	75.0 percentage of participants Interval 42.8 to 94.5

SECONDARY outcome

Timeframe: Up to 799 days of treatment

ORR is defined as the percentage of participants with a best overall response of confirmed CR or confirmed PR. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion.

Outcome measures

Outcome measures
Measure	Sunitinib n=12 Participants Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Objective Response Rate (ORR)	50.0 percentage of participants Interval 21.1 to 78.9

SECONDARY outcome

Timeframe: Up to 799 days of treatment

Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants.

Outcome measures

Outcome measures
Measure	Sunitinib n=12 Participants Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Tumor Shrinkage Cycle 1 (n=1)	-20.0 percent change Standard Deviation NA Only 1 participant was analyzed in this cycle
Tumor Shrinkage Cycle 2 (n=11)	-14.4 percent change Standard Deviation 13.43
Tumor Shrinkage Cycle 3 (n=12)	-18.0 percent change Standard Deviation 17.70
Tumor Shrinkage Cycle 5 (n=9)	-26.0 percent change Standard Deviation 10.03
Tumor Shrinkage Cycle 7 (n=9)	-28.5 percent change Standard Deviation 11.86
Tumor Shrinkage Cycle 9 (n=9)	-31.8 percent change Standard Deviation 17.20
Tumor Shrinkage Cycle 11 (n=9)	-36.4 percent change Standard Deviation 30.11
Tumor Shrinkage Cycle 13 (n=9)	-28.8 percent change Standard Deviation 16.92
Tumor Shrinkage Cycle 14 (n=1)	1.7 percent change Standard Deviation NA Only 1 participant was analyzed in this cycle
Tumor Shrinkage Cycle 15 (n=7)	-32.5 percent change Standard Deviation 17.29
Tumor Shrinkage Cycle 16 (n=1)	-34.7 percent change Standard Deviation NA Only 1 participant was analyzed in this cycle
Tumor Shrinkage Cycle 17 (n=5)	-38.7 percent change Standard Deviation 15.41
Tumor Shrinkage Cycle 18 (n=1)	-43.1 percent change Standard Deviation NA Only 1 participant was analyzed in this cycle
Tumor Shrinkage Cycle 19 (n=4)	-37.8 percent change Standard Deviation 19.21
Tumor Shrinkage Cycle 21 (n=4)	-35.8 percent change Standard Deviation 19.19
Tumor Shrinkage Cycle 23 (n=4)	-35.1 percent change Standard Deviation 22.82
Tumor Shrinkage Cycle 25 (n=4)	-32.6 percent change Standard Deviation 19.64
Tumor Shrinkage Cycle 27 (n=3)	-30.8 percent change Standard Deviation 26.68
Tumor Shrinkage Cycle 28 (n=2)	-40.4 percent change Standard Deviation 9.72
Tumor Shrinkage Cycle 29 (n=1)	3.3 percent change Standard Deviation NA Only 1 participant was analyzed in this cycle
Tumor Shrinkage Maximum Reduction (n=12)	-34.8 percent change Standard Deviation 28.76

SECONDARY outcome

Timeframe: Up to 799 days of treatment

PFS is defined as the time from registration to first documentation of progressive disease (PD) or to death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Sunitinib n=12 Participants Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Progression-free Survival (PFS)	16.8 Months Interval 9.3 to 26.2

SECONDARY outcome

Timeframe: Up to 3 years from the last subject registration to the study

Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause.

Outcome measures

Outcome measures
Measure	Sunitinib n=12 Participants Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Overall Survival (OS)	NA Months Interval 22.0 to Median OS had not yet been reached due to short of events.

SECONDARY outcome

Timeframe: Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1

Population: The pharmacokinetics analysis set was defined as all participants who had at least one plasma concentration data at trough sampling with steady-state condition. "n" in the measured values means number of participants analyzed.

Reference dose is 37.5 mg. Dose-corrected concentration is calculated from the following formula, "observed concentration multiplied by 37.5" over "actual dose". SU012662 is an active metabolite of sunitinib.

Outcome measures

Outcome measures
Measure	Sunitinib n=11 Participants Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). Sunitinib (Cycle 1 Day 15, n=10)	53.9 nanogram/mL Standard Deviation 17.6
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). Sunitinib (Cycle 2 Day 1, n=2)	41.7 nanogram/mL Standard Deviation 21.9
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). Sunitinib (Cycle 3 Day 1, n=8)	49.9 nanogram/mL Standard Deviation 19.7
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). Sunitinib (Cycle 4 Day 1, n=5)	53.5 nanogram/mL Standard Deviation 24.6
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). SU012662 (Cycle 1 Day 15, n=10)	23.7 nanogram/mL Standard Deviation 7.00
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). SU012662 (Cycle 2 Day 1, n=2)	21.2 nanogram/mL Standard Deviation 6.36
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). SU012662 (Cycle 3 Day 1, n=8)	25.7 nanogram/mL Standard Deviation 9.14
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). SU012662 (Cycle 4 Day 1, n=5)	19.6 nanogram/mL Standard Deviation 7.44
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). Total drug (Cycle 1 Day 15, n=10)	77.5 nanogram/mL Standard Deviation 20.9
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). Total drug (Cycle 2 Day 1, n=2)	62.9 nanogram/mL Standard Deviation 28.3
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). Total drug (Cycle 3 Day 1, n=8)	75.5 nanogram/mL Standard Deviation 26.5
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). Total drug (Cycle 4 Day 1, n=5)	73.0 nanogram/mL Standard Deviation 28.8

Adverse Events

Sunitinib

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sunitinib n=12 participants at risk Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Gastrointestinal disorders Enterocolitis	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholangitis	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholecystitis acute	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Convulsion	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Loss of consciousness	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	Sunitinib n=12 participants at risk Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
Skin and subcutaneous tissue disorders Eczema	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hair colour changes	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Nail disorder	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Onychomadesis	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	66.7% 8/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin discolouration	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin reaction	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	66.7% 8/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dry skin	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis acneiform	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Anaemia	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Disseminated intravascular coagulation	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Left ventricular dysfunction	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Hypothyroidism	33.3% 4/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctival haemorrhage	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Diplopia	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Eyelash discolouration	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Ocular hyperaemia	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distension	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Ascites	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	83.3% 10/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dysphagia	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastritis	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gingivitis	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Glossitis	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haemorrhoids	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Hypoaesthesia oral	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Loose tooth	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	41.7% 5/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oral dysaesthesia	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Periodontitis	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Reflux oesophagitis	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Toothache	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	41.7% 5/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Face oedema	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	58.3% 7/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Malaise	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	25.0% 3/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema	33.3% 4/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	41.7% 5/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholangitis	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic failure	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Encephalitis herpes	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Enteritis infectious	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Enterocolitis infectious	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Hordeolum	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Infected epidermal cyst	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	41.7% 5/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral herpes	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pyoderma	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Skin candida	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Trichophytosis	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Contusion	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Wound	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood alkaline phosphatase increased	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood urine present	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Electrocardiogram QT prolonged	25.0% 3/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Gamma-glutamyltransferase increased	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Lipase increased	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Lymphocyte count decreased	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Neutrophil count decreased	33.3% 4/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Platelet count decreased	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Protein urine present	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Urine output decreased	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations White blood cell count decreased	25.0% 3/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	33.3% 4/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperamylasaemia	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoalbuminaemia	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	25.0% 3/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysaesthesia	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	41.7% 5/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	58.3% 7/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypoaesthesia	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Haematuria	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Nephrotic syndrome	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Pollakiuria	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Proteinuria	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Scrotal haematocoele	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER