PREA, PK And Safety PASS Study Of IV Pantoprazole In Pedi... | NCT02401035

NCT02401035

ID	Type	Description
2014-002182-29	EudraCT Number
B1791089	Other Identifier	Study Number
GERD	Other Identifier	Alias Study Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
IV pantoprazole	Experimental	Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight.	Drug: IV pantoprazole

Name	Type	Description	Arm Group Labels	Other Names
IV pantoprazole	Drug	Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight	IV pantoprazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clearance (CL) of Pantoprazole	Data reported below is combined for Days 1, 2 and 7.	0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7
Volume of Distribution (Vd) of Pantoprazole	Data reported below is combined for Days 1, 2 and 7.	0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7

Secondary Outcomes

Measure	Description	Time Frame
Maximum Plasma Concentration (Cmax) of Pantoprazole: Single Dose	The results for Cmax were presented separately for single dose and multiple doses.	0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1
Cmax of Pantoprazole: Multiple Dose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects aged 1 to 16 years who in the judgment of the investigator are candidates for gastric acid suppression therapy (ie, those with a presumptive diagnosis of GERD, a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD) and whom the investigator judges would need to receive IV PPI therapy for at least 4 days.
Body weight > 5th percentile for age.
Y-site or dedicated IV line for administration of pantoprazole sodium.
Expected survival for at least 30 days.
Fertile male and female subjects of childbearing potential at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. Female subjects of non-childbearing potential must be premenarchal, have undergone hysterectomy with bilateral oophorectomy, have medically confirmed ovarian failure, or achieved post-menopausal status.

Exclusion Criteria:

Participation in other studies involving investigational drug(s) or treatment with an investigational drug within 30 days or 5 half lives prior to study entry and/or during study participation.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Pregnant females; breastfeeding females; fertile male subjects, and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after last dose of investigational product.
Serum CK levels >3x ULN.
Known history of HIV or clinical manifestations of AIDS.
Known hypersensitivity to PPIs or to any substituted benzimidazole or to any of the excipients.
History of treatment with any PPI within 2 days (48 hours) before investigational product dosing on Day 1.
Use of H2RAs, sucralfate, misoprostol, or prokinetic agents, and bismuth preparations within 1 day (24 hours) before investigational product dosing on Day 1.
Any disorder requiring chronic (every day) use of warfarin, carbamazepine, or phenytoin, methotrexate, atazanavir or nelfinavir, clopidogrel, and potent inhibitors and inducers of CYP2C19.
Chronic (daily) use of glucocorticoids. Steroid inhalers and topical steroids may be used.
Active malignancy of any type, or history of a malignancy (Subject with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable).
ALT or BUN >2.0 ULN or estimated creatinine >1.5 X ULN for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before Screening.
In the Investigator's opinion, a chronic condition (eg, diabetes, epilepsy), which is either not stable or well controlled and may interfere with the conduct of the study.
History of sensitivity to heparin or heparin induced thrombocytopenia.

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Children's Health Specialty Center Dallas Campus		Dallas	Texas	75207	United States
Children's Medical Center Dallas

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1 (>=1 to < 2 Years)	Participants aged greater than or equal to (>=) 1 year to less than (<) 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 milligrams (mg), once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 7, 2018	Mar 11, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Data reported below is combined for Days 2 and 7.

All enrolled participants were included in analysis.

Arm/Group Information

ID	Title	Description
BG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
BG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG0001.00± 0.000 BG0019.31± 4.729 BG0028.00± 5.323

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0017 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Clearance (CL) of Pantoprazole

Data reported below is combined for Days 1, 2 and 7.

The pharmacokinetic (PK) parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter per hour

0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units	Counts
Participants	OG0002 OG00116

Title

Denominators

Categories

Title	Measurements
	OG0001.930± 82 OG0014.739± 71

Primary

Volume of Distribution (Vd) of Pantoprazole

Data reported below is combined for Days 1, 2 and 7.

The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter

0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units	Counts
Participants

Secondary

Maximum Plasma Concentration (Cmax) of Pantoprazole: Single Dose

The results for Cmax were presented separately for single dose and multiple doses.

The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanogram per milliliter (ng/mL)

0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units	Counts
Participants

Secondary

Cmax of Pantoprazole: Multiple Dose

Data reported below is combined for Days 2 and 7.

The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units	Counts
Participants

Secondary

Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Single Dose

The results for AUC24 were presented separately for single dose and multiple doses.

The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanogram* hour per milliliter (ng*hr/mL)

0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 24 hours post dose on Day 1 (pre dose on Day 2)

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units	Counts
Participants

Secondary

Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Multiple Dose

Data reported below is combined for Days 2 and 7.

The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest. Since dosing interval between 2 doses are 24 hours, individual post-hoc estimated AUC from population PK analysis is AUC24. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Secondary

Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Single Dose

The results for AUCinf were presented separately for single dose and multiple doses.

The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units	Counts
Participants

Secondary

Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Multiple Dose

Data reported below is combined for Days 2 and 7.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units

Secondary

Terminal Half-Life (t1/2) of Pantoprazole

Data reported below is combined for Days 1, 2 and 7.

The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.

Posted

Mean

Standard Deviation

Hours

0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units	Counts
Participants

Secondary

Number of Participants According to CYP2C19 Genotyping

CYP2C19 genotype was assessed in pediatric participants who received intravenous pantoprazole sodium and determined the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Day 1

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units	Counts
Participants

Secondary

Number of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product; the event need not necessarily had a causal relationship with the treatment or usage.

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

From Day 1 up to 34 days after the last dose (maximum up to 41 days)

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units	Counts
Participants

Secondary

Number of Participants With Laboratory Abnormalities of Potential Clinical Concern

Number of participants with abnormalities in laboratory parameters of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Up to Day 9

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units	Counts
Participants

Secondary

Number of Participants With Physical Examination Abnormalities of Potential Clinical Concern

Number of participants with abnormalities in physical examination of potential concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

At screening (Day 0)

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units	Counts
Participants

Secondary

Number of Participants With Blood Pressure Abnormalities of Potential Clinical Concern

Number of participants with abnormalities in blood pressure of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.

Safety analysis set included all participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Up to Day 9

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units	Counts
Participants

Secondary

Number of Participants With Pulse Rate Abnormalities of Potential Clinical Concern

Number of participants with abnormalities in pulse rate of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.

Safety analysis set included all the participants who received at least 1 dose of study medication.

Posted

Count of Participants

Participants

Up to Day 9

ID	Title	Description
OG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.
OG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1 (>=1 to < 2 Years)	Participants aged >= 1 year to < 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.	0	2	0	2	0	2
EG001	Cohort 2 (>=2 to <16 Years)	Participants aged >= 2 to < 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning.	0	16	1	16	8	16

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Rotavirus infection	Infections and infestations	MedDRA v25.1	Systematic Assessment		EG0000 affected2 at risk EG0011 affected16 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vertigo	Ear and labyrinth disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0013 affected16 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Nausea	Gastrointestinal disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Vomiting	Gastrointestinal disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected16 at risk
Catheter site erythema	General disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Catheter site pain	General disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Catheter site pruritus	General disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Chest pain	General disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Oedema peripheral	General disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Pyrexia	General disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Vessel puncture site erythema	General disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Gastroenteritis	Infections and infestations	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected16 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Epiphyses delayed fusion	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected16 at risk
Headache	Nervous system disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0012 affected16 at risk
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA v25.1	Systematic Assessment	EG0000 affected2 at risk EG0011 affected16 at risk

ID	Term
D005764	Gastroesophageal Reflux

ID	Term
D000077402	Pantoprazole

Ancestor Terms

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Units	Counts
Participants	OG0002 OG00115

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases