Trial Outcomes & Findings for PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects (NCT NCT02401035)
NCT ID: NCT02401035
Last Updated: 2024-04-09
Results Overview
Data reported below is combined for Days 1, 2 and 7.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
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
Results posted on
2024-04-09
Participant Flow
A total of 19 participants were enrolled. Nineteen participants were randomized and assigned to a study treatment out of which, 1 participant was not randomized to any study treatment.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
16
|
|
Overall Study
Treated
|
2
|
16
|
|
Overall Study
COMPLETED
|
2
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects
Baseline characteristics by cohort
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=3 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 Participants
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.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
1.00 Years
STANDARD_DEVIATION 0.000 • n=5 Participants
|
9.31 Years
STANDARD_DEVIATION 4.729 • n=7 Participants
|
8.00 Years
STANDARD_DEVIATION 5.323 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 7Population: The pharmacokinetic (PK) parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.
Data reported below is combined for Days 1, 2 and 7.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 Participants
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.
|
|---|---|---|
|
Clearance (CL) of Pantoprazole
|
1.930 Liter per hour
Geometric Coefficient of Variation 82
|
4.739 Liter per hour
Geometric Coefficient of Variation 71
|
PRIMARY outcome
Timeframe: 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 7Population: The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.
Data reported below is combined for Days 1, 2 and 7.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 Participants
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.
|
|---|---|---|
|
Volume of Distribution (Vd) of Pantoprazole
|
1.622 Liter
Geometric Coefficient of Variation 58
|
5.584 Liter
Geometric Coefficient of Variation 74
|
SECONDARY outcome
Timeframe: 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1Population: The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.
The results for Cmax were presented separately for single dose and multiple doses.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 Participants
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.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Pantoprazole: Single Dose
|
5259 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 60
|
4280 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
SECONDARY outcome
Timeframe: 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 7Population: 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.
Data reported below is combined for Days 2 and 7.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=15 Participants
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.
|
|---|---|---|
|
Cmax of Pantoprazole: Multiple Dose
|
5259 ng/mL
Geometric Coefficient of Variation 60
|
4423 ng/mL
Geometric Coefficient of Variation 47
|
SECONDARY outcome
Timeframe: 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)Population: The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.
The results for AUC24 were presented separately for single dose and multiple doses.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 Participants
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.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Single Dose
|
6022 Nanogram* hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 84
|
6533 Nanogram* hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 62
|
SECONDARY outcome
Timeframe: 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 7Population: 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.
Data reported below is combined for Days 2 and 7.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=15 Participants
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.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Multiple Dose
|
5705 ng*hr/mL
Geometric Coefficient of Variation 82
|
6690 ng*hr/mL
Geometric Coefficient of Variation 60
|
SECONDARY outcome
Timeframe: 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1Population: The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.
The results for AUCinf were presented separately for single dose and multiple doses.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 Participants
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.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Single Dose
|
6022 ng*hr/mL
Geometric Coefficient of Variation 84
|
6542 ng*hr/mL
Geometric Coefficient of Variation 62
|
SECONDARY outcome
Timeframe: 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 7Population: 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.
Data reported below is combined for Days 2 and 7.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=15 Participants
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.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Multiple Dose
|
5708 ng*hr/mL
Geometric Coefficient of Variation 82
|
6707 ng*hr/mL
Geometric Coefficient of Variation 61
|
SECONDARY outcome
Timeframe: 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 7Population: The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.
Data reported below is combined for Days 1, 2 and 7.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 Participants
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.
|
|---|---|---|
|
Terminal Half-Life (t1/2) of Pantoprazole
|
2.805 Hours
Standard Deviation 0.1909
|
3.767 Hours
Standard Deviation 0.6802
|
SECONDARY outcome
Timeframe: Day 1Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants According to CYP2C19 Genotyping
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 34 days after the last dose (maximum up to 41 days)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
0 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to Day 9Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities of Potential Clinical Concern
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At screening (Day 0)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With Physical Examination Abnormalities of Potential Clinical Concern
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 9Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With Blood Pressure Abnormalities of Potential Clinical Concern
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 9Population: Safety analysis set included all the participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 Participants
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With Pulse Rate Abnormalities of Potential Clinical Concern
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1 (>=1 to < 2 Years)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2 (>=2 to <16 Years)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 participants at risk
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Cohort 1 (>=1 to < 2 Years)
n=2 participants at risk
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.
|
Cohort 2 (>=2 to <16 Years)
n=16 participants at risk
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.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
18.8%
3/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
12.5%
2/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
General disorders
Catheter site erythema
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
General disorders
Catheter site pain
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
General disorders
Catheter site pruritus
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
General disorders
Vessel puncture site erythema
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
12.5%
2/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Epiphyses delayed fusion
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
12.5%
2/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
12.5%
2/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/2 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
6.2%
1/16 • From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Same event may appear as both serious adverse event (SAE) and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 dose of study medication.
|
Additional Information
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