Trial Outcomes & Findings for Subcutaneous Rehydration Compared to Intravenous Rehydration (NCT NCT00773175)

Results Overview

It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

148 participants

Primary outcome timeframe

During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Results posted on

2018-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Subcutaneous Hylenex Participants received isotonic fluid rehydration by subcutaneous administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid Participants received isotonic fluid rehydration by intravenous injection.
Overall Study STARTED	73	75
Overall Study Initial Fluids Via Randomized Route	73	59
Overall Study Initial Fluids Via Subcutaneous Rescue	0	15
Overall Study No Fluids Received	0	1
Overall Study COMPLETED	71	73
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Subcutaneous Hylenex Participants received isotonic fluid rehydration by subcutaneous administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid Participants received isotonic fluid rehydration by intravenous injection.
Overall Study Adverse Event	2	0
Overall Study Consent Withdrawn	0	2

Baseline Characteristics

Subcutaneous Rehydration Compared to Intravenous Rehydration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous injection.	Total n=148 Participants Total of all reporting groups
Age, Continuous	2.1 years STANDARD_DEVIATION 1.72 • n=5 Participants	2.4 years STANDARD_DEVIATION 2.07 • n=7 Participants	2.3 years STANDARD_DEVIATION 1.91 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	36 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	39 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized White	39 Participants n=5 Participants	40 Participants n=7 Participants	79 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: Intent-to-Treat (ITT) Population: all randomly assigned participants for whom the treatment was attempted, (i.e., infusion device placement was initiated)

It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants Emergency department stay only	334.3 milliliters Standard Deviation 226.4	299.6 milliliters Standard Deviation 252.33	—
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants Emergency department plus hospital stay	365.0 milliliters Standard Deviation 324.57	455.8 milliliters Standard Deviation 597.43	—

PRIMARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.

It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=59 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants Emergency department plus hospital stay	365.0 milliliters Standard Deviation 324.57	579.4 milliliters Standard Deviation 618.49	—
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants Emergency department stay only	334.3 milliliters Standard Deviation 226.4	380.8 milliliters Standard Deviation 223.08	—

PRIMARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.

It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=15 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Rescued Participants Emergency department plus hospital stay	388.3 milliliters Standard Deviation 281.13	—	—
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Rescued Participants Emergency department stay only	315.3 milliliters Standard Deviation 150.38	—	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population

It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants Emergency department plus hospital stay	365.4 milliliters Standard Deviation 324.21	455.8 milliliters Standard Deviation 597.43	—
Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants Emergency department stay only	334.7 milliliters Standard Deviation 225.94	299.6 milliliters Standard Deviation 252.33	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: Randomized Population: all participants who were assigned a patient randomization number

It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the Food and Drug Administration (FDA) removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: Randomized Population. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were to be analyzed.

It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the FDA removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: Randomized Participants. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.

It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the FDA removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population

The mean flow rate was averaged over any 60-minute period of time.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants Emergency department plus hospital stay	183.8 milliliters per hour Standard Deviation 94.61	166.1 milliliters per hour Standard Deviation 142.52	—
Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants Emergency department stay only	186.4 milliliters per hour Standard Deviation 92.21	179.6 milliliters per hour Standard Deviation 141.19	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.

The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=59 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Flow Rate, Delivered Per Unit Time, for All Non-rescued Participants Emergency department plus hospital stay	183.8 milliliters per hour Standard Deviation 94.61	211.1 milliliters per hour Standard Deviation 127.44	—
Mean Flow Rate, Delivered Per Unit Time, for All Non-rescued Participants Emergency department stay only	186.4 milliliters per hour Standard Deviation 92.21	228.3 milliliters per hour Standard Deviation 118.82	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.

The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=15 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Flow Rate, Delivered Per Unit Time, for All Rescued Participants Emergency department plus hospital stay	139.1 milliliters per hour Standard Deviation 80.27	—	—
Mean Flow Rate, Delivered Per Unit Time, for All Rescued Participants Emergency department stay only	149.8 milliliters per hour Standard Deviation 79.53	—	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population. Only those participants with evaluable data (known volume and known baseline body weight) were analyzed.

The mean flow rate was averaged over any 60-minute period of time.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=70 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=73 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Randomized Participants Emergency department plus hospital stay	15.4 milliliters per kilogram per hour Standard Deviation 5.62	12.3 milliliters per kilogram per hour Standard Deviation 9.50	—
Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Randomized Participants Emergency department stay only	15.6 milliliters per kilogram per hour Standard Deviation 5.33	13.3 milliliters per kilogram per hour Standard Deviation 9.50	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed. Only those participants with evaluable data (known volume and known baseline body weight) were analyzed.

The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=70 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=57 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Non-rescued Participants Emergency department plus hospital stay	15.4 milliliters per kilogram per hour Standard Deviation 5.62	15.7 milliliters per kilogram per hour Standard Deviation 7.80	—
Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Non-rescued Participants Emergency department stay only	15.6 milliliters per kilogram per hour Standard Deviation 5.33	17.1 milliliters per kilogram per hour Standard Deviation 7.14	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed. Only those participants with evaluable data (known volume and known baseline body weight) were analyzed.

The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=14 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Rescued Participants Emergency department plus hospital stay	14.4 milliliters per kilogram per hour Standard Deviation 6.47	—	—
Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Rescued Participants Emergency department stay only	15.4 milliliters per kilogram per hour Standard Deviation 6.07	—	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population

The maximum flow rate was averaged over any 60-minute period of time.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants Achieving a Maximum Flow Rate of > 2 Milliliters Per Minute (mL/Min), as an Indication of Successful Hydration	68 Participants	57 Participants	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population

The number of participants administered at least 20 mL total volume was assessed.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants Administered at Least 200 Milliliter (mL) Total Volume at a Single Infusion Site, From the Start to the Cessation of Fluid Administration	18 Participants	27 Participants	—

SECONDARY outcome

Timeframe: up to 7 days after hospital discharge

Population: Safety Population: all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)

Adverse events (AEs) are defined as any untoward medical occurrence in a participant administered a product, which did not necessarily have a causal relationship with the treatment. Treatment-emergent adverse events (TEAEs) are defined as those events that occurred on or after the first injection device insertion attempt.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants With the Indicated Type of Adverse Events At least 1 AE	73 Participants	68 Participants	—
Number of Participants With the Indicated Type of Adverse Events At least 1 infusion site AE	73 Participants	63 Participants	—
Number of Participants With the Indicated Type of Adverse Events at least 1 AE related to infusion fluid	72 Participants	32 Participants	—
Number of Participants With the Indicated Type of Adverse Events At least 1 AE related to hylenex	67 Participants	14 Participants	—

SECONDARY outcome

Timeframe: Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: Safety Population. Only those participants for which fluid administration was initiated were analyzed.

Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion. Not Rel Dehy = Abnormal, Not Related to Dehydration; Rel Dehy = Abnormal, Related to Dehydration. The investigator assessed findings as abnormal.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=59 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued n=15 Participants Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Endocrine/Metabolism and Nutrition: Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Other: Not Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Other: Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Musculoskeletal: Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Head, eyes, ears: Not Rel Dehy	1 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Head, eyes, ears: Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Neck/upper airway: Not Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Neck/upper airway: Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Heart: Not Rel Dehy	0 Participants	1 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Heart: Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Lungs: Not Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Lungs: Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Abdomen: Not Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Abdomen: Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Skin: Not Rel Dehy	0 Participants	1 Participants	2 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Skin: Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Musculoskeletal: Not Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Endocrine/Metabolism and Nutrition: Not Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Extremities: Not Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Extremities: Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Neurological: Not Rel Dehy	1 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Neurological: Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Vascular/Circulatory: Not Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Vascular/Circulatory: Rel Dehy	1 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Lymphatic: Not Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Lymphatic: Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Reproductive: Not Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Reproductive: Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Renal/Urinary: Not Rel Dehy	0 Participants	0 Participants	0 Participants
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration Renal/Urinary: Rel Dehy	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: Safety Population. Only those participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=68 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=53 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued n=14 Participants Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Change From Baseline in Heart Rate	-6.9 beats per minute Standard Deviation 17.38	-4.8 beats per minute Standard Deviation 18.64	-11.3 beats per minute Standard Deviation 24.68

SECONDARY outcome

Timeframe: Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: Safety Population. Only those participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=68 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=52 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued n=14 Participants Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Change From Baseline in Respiratory Rate	-4.8 breaths per minute Standard Deviation 9.76	-1.3 breaths per minute Standard Deviation 7.96	-2.6 breaths per minute Standard Deviation 13.36

SECONDARY outcome

Timeframe: Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: Safety Population. Only those participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=61 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=49 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued n=14 Participants Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Systolic blood pressure	3.2 millimeters of mercury (mmHg) Standard Deviation 16.15	1.1 millimeters of mercury (mmHg) Standard Deviation 15.49	-4.0 millimeters of mercury (mmHg) Standard Deviation 24.17
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Diastolic blood pressure	-0.2 millimeters of mercury (mmHg) Standard Deviation 12.43	0.7 millimeters of mercury (mmHg) Standard Deviation 12.45	-2.9 millimeters of mercury (mmHg) Standard Deviation 23.07

SECONDARY outcome

Timeframe: Before infusion (Baseline); after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: Safety Population. Only those participants with available data were analyzed.

The infusion site was assessed for pain at two time points: after placement of the infusion device but before fluid infusion and at the end of infusion. Pain was recorded using the FLACC pain scale for children less than 3 years of age. Scores on the scale ranged from 0 (no hurt) to 10 (hurt worst).

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=59 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=39 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued n=15 Participants Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Mean Change From Baseline in the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale Score	-4.4 score on a scale Standard Deviation 3.45	-5.2 score on a scale Standard Deviation 2.94	-3.8 score on a scale Standard Deviation 2.11

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.

Data are reported for the initial fluid administered.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=59 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued n=15 Participants Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants With the Indicated Type of Fluid Administered Lactated Ringers	28 Participants	9 Participants	6 Participants
Number of Participants With the Indicated Type of Fluid Administered Normal saline (NS)	44 Participants	49 Participants	9 Participants
Number of Participants With the Indicated Type of Fluid Administered D5 1/2 NS without potassium chloride (KCL)	0 Participants	1 Participants	0 Participants
Number of Participants With the Indicated Type of Fluid Administered D5 1/2 NS with KCL	0 Participants	0 Participants	0 Participants
Number of Participants With the Indicated Type of Fluid Administered Other	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: first hour of infusion

Population: ITT Population

Infusion duration was assessed as a measure of the time required to complete the initial infusion of 20 mL/kg.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Infusion Duration During the Initial Infusion	1.0 hours Standard Deviation 0.13	0.8 hours Standard Deviation 0.42	—

SECONDARY outcome

Timeframe: Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population. Only those participants contributing data at the indicated time point were assessed.

Hydration status was assessed clinically using the Gorelick 10-item scale: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate, and capillary refill time at the fingertip. Scores ranged from 0 (less severe impairment) to 10 (more severe impairment). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=73 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Change From Baseline in Hydration Status According to the Gorelick Assessment at the End of Fluid Infusion	-2.6 score on a scale Standard Deviation 1.26	-2.2 score on a scale Standard Deviation 1.64	—

SECONDARY outcome

Timeframe: Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population. Only those participants contributing data at the indicated time point were assessed.

Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] / Baseline value) \* 100.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=68 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=67 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Percent Change From Baseline in Body Weight	2.9 percent change Standard Deviation 2.52	3.8 percent change Standard Deviation 15.17	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population

Participants for whom parenteral access by the randomized route of administration could not be achieved after a reasonable number of attempts and for whom the investigator had deemed the access by that route a failure were expected to receive fluid administration by other means, designated as "rescue route" for the purpose of this study. This rescue route may have included venous cut-down, central venous line, interosseous access, etc., and for those participants initially randomly assigned to IV fluid administration, SC fluid administration by hylenex-facilitated infusion.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants With the Indicated Type of Rescue Route Therapy Administered hylenex-facilitated SC	0 Participants	15 Participants	—
Number of Participants With the Indicated Type of Rescue Route Therapy Administered Other type of rescue	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population

A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV). Question 1: Was the participant successfully hydrated using the randomized route of administration?; Question 2: Overall, was the procedure of fluid infusion easy to perform?; Question 3: Were there any unacceptable side effects from the therapy?; Question 4: Would you consider using this hydration therapy for this indication in the future?

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire Question 1 · Yes	68 Participants	57 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire Question 1 · No	4 Participants	13 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire Question 1 · Missing	1 Participants	5 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire Question 2 · Yes	69 Participants	49 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire Question 2 · No	4 Participants	21 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire Question 2 · Missing	0 Participants	5 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire Question 3 · Yes	3 Participants	4 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire Question 3 · No	70 Participants	66 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire Question 3 · Missing	0 Participants	5 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire Question 4 · Yes	71 Participants	64 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire Question 4 · No	2 Participants	6 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire Question 4 · Missing	0 Participants	5 Participants	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population

A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV).

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? Degree of Difficulty: Missing	2 Participants	0 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? Effectiveness: Less Effective	3 Participants	1 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? Effectiveness: Same Effectiveness	58 Participants	41 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? Effectiveness: More Effective	11 Participants	0 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? Effectiveness: Missing	1 Participants	0 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? Degree of Difficulty: Less Difficult	57 Participants	2 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? Degree of Difficulty: Same Difficulty	11 Participants	12 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? Degree of Difficulty: More Difficult	3 Participants	28 Participants	—
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? Not applicable: no prior experience with alternate	0 Participants	33 Participants	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population. Only participants with a response of "Yes" to Question 2 contributed responses for Question 3.

A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV). Question 1: Do you believe the method of therapy was successful in your child's rehydration?; Question 2: Have you or your child ever previously had IV fluids (for SC Group) / SC fluids (for IV Group)?; Question 3: If the response to Question 2 was "yes," how does this compare to prior experience with IV (for SC Group) / SC (for IV Group)?; Question 4: Should your child(ren) need rehydration treatment in the future, would you opt for this procedure?; Question 5: Should you need rehydration treatment in the future, would you opt for this procedure?; Question 6: What is your global satisfaction with the study procedure?

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 1, yes	70 Participants	59 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 1, no	3 Participants	8 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 1, missing	0 Participants	8 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 2, yes	47 Participants	2 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 2, no	26 Participants	63 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 2, not done	0 Participants	2 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 2, missing	0 Participants	8 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 3, worse	2 Participants	0 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 3, same	9 Participants	2 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 3, better	35 Participants	0 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 3, missing	1 Participants	0 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 4, yes	65 Participants	56 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 4, no	4 Participants	11 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 4, not done	2 Participants	0 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 4, unknown	1 Participants	0 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 4, missing	1 Participants	8 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 5, yes	68 Participants	55 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 5, no	4 Participants	12 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 5, not done	1 Participants	0 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 5, missing	0 Participants	8 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 6, very unsatisfied	3 Participants	8 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 6, unsatisfied	1 Participants	4 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 6, satisfied	26 Participants	31 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 6, very satisfied	43 Participants	24 Participants	—
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire Question 6, missing	0 Participants	8 Participants	—

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.

In the event that the degree of local infusion site swelling became unacceptable for any reason (e.g., a 30% or greater increase from the baseline circumference of the infused thigh or in the clinical judgment of the investigator), the infusion rate was decreased or the infusion site was changed.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=59 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued n=15 Participants Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration 1 administration site	72 Participants	59 Participants	15 Participants
Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration 2 administration sites	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)

Population: ITT Population

In the event that the degree of local infusion site swelling became unacceptable for any reason (e.g., a 30% or greater increase from the baseline circumference of the infused thigh or in the clinical judgment of the investigator), the infusion rate was decreased or the infusion site was changed.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants Experiencing Reductions in Flow Rate	43 Participants	39 Participants	—

SECONDARY outcome

Timeframe: average of approximately 3 minutes

Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.

Data were collected for the level of staff training for the person who performed the needle placement.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=59 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued n=15 Participants Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training Physician	28 Participants	4 Participants	1 Participants
Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training Registered nurse	35 Participants	48 Participants	10 Participants
Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training Physician assistant	2 Participants	2 Participants	1 Participants
Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training Nurse practitioner	6 Participants	0 Participants	0 Participants
Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training Licensed vocational nurse	0 Participants	0 Participants	2 Participants
Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training Other	2 Participants	5 Participants	1 Participants

SECONDARY outcome

Timeframe: average of approximately 3 minutes

Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.

Data were collected for the number of additional personnel involved in needle placement.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=59 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued n=15 Participants Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement 0	20 Participants	1 Participants	1 Participants
Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement 1	36 Participants	34 Participants	5 Participants
Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement 2	14 Participants	20 Participants	7 Participants
Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement 3	3 Participants	3 Participants	2 Participants
Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement 4	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: up to approximately 26 hours

Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants with available data were analyzed.

Data are reported from the start of infusion to the time of ED discharge.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=72 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=59 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued n=15 Participants Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Time From the Start of Infusion to the Time of Emergency Department (ED) Discharge	4.0 hours Standard Deviation 4.26	3.1 hours Standard Deviation 1.92	4.7 hours Standard Deviation 4.64

SECONDARY outcome

Timeframe: up to approximately 110 and 220 minutes for the SC and IV arms, respectively

Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.

Data are reported for the time from randomization to the start of fluid infusion for all randomized participants.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=74 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Time From Randomization to the First Drop of Fluid Infusion	37 minutes Interval 31.0 to 41.0	42.5 minutes Interval 37.0 to 52.0	—

SECONDARY outcome

Timeframe: average of approximately 3 minutes

Population: ITT Population

Data are reported for the number of needle stick attempts needed to initiate fluid administration.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration 1	69 Participants	54 Participants	—
Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration 2	4 Participants	13 Participants	—
Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration 3	0 Participants	7 Participants	—
Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration >3	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: average of approximately 3 minutes

Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.

Data are reported for the type of infusion device used.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=59 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued n=15 Participants Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants for Which the Indicated Type of Infusion Device Was Used Angiocatheter	63 Participants	57 Participants	15 Participants
Number of Participants for Which the Indicated Type of Infusion Device Was Used Butterfly needle	10 Participants	1 Participants	0 Participants
Number of Participants for Which the Indicated Type of Infusion Device Was Used Other	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: average of approximately 3 minutes

Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.

Data are reported for the gauge of infusion device used.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=59 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued n=15 Participants Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants for Which the Indicated Gauge for Infusion Device Was Used 20	2 Participants	0 Participants	0 Participants
Number of Participants for Which the Indicated Gauge for Infusion Device Was Used 22	28 Participants	22 Participants	5 Participants
Number of Participants for Which the Indicated Gauge for Infusion Device Was Used 23	4 Participants	1 Participants	0 Participants
Number of Participants for Which the Indicated Gauge for Infusion Device Was Used 24	31 Participants	33 Participants	10 Participants
Number of Participants for Which the Indicated Gauge for Infusion Device Was Used 25	8 Participants	2 Participants	0 Participants
Number of Participants for Which the Indicated Gauge for Infusion Device Was Used 26	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: up to approximately 26 hours

Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.

Participants were discharged from the ED to home or the hospital to continue hydration therapy.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=73 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=74 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants Discharged From the ED to Home or the Hospital Home	60 Participants	64 Participants	—
Number of Participants Discharged From the ED to Home or the Hospital Hospital	13 Participants	10 Participants	—

SECONDARY outcome

Timeframe: from randomization up to approximately 98 hours

Population: ITT Population. Only those participants who were re-hospitalized or had an Emergency Department visit after initial discharge to home were analyzed.

Participants were discharged from the ED to home or the hospital to continue hydration therapy.

Outcome measures

Outcome measures
Measure	Subcutaneous Hylenex n=9 Participants Participants received isotonic fluid rehydration by subcutaneous (SC) administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=10 Participants Participants received isotonic fluid rehydration by intravenous (IV) injection.	Intravenous Isotonic Fluid: SC Rescued Participants randomized to receive IV isotonic fluid were rescued via the hylenex-facilitated SC-rescue route after IV access could not be established.
Number of Participants With the Indicated Reason for Rehospitalization Within 48 and 72 Hours After Discharge Other	7 Participants	8 Participants	—
Number of Participants With the Indicated Reason for Rehospitalization Within 48 and 72 Hours After Discharge Retreatment for dehydration	2 Participants	2 Participants	—

Adverse Events

Subcutaneous Hylenex

Serious events: 3 serious events

Other events: 73 other events

Deaths: 1 deaths

Intravenous Isotonic Fluid

Serious events: 4 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Subcutaneous Hylenex n=73 participants at risk Participants received isotonic fluid rehydration by subcutaneous administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 participants at risk Participants received isotonic fluid rehydration by intravenous injection.
General disorders Pyrexia	0.00% 0/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	1.3% 1/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)
Metabolism and nutrition disorders Ongoing dehydration	0.00% 0/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	1.3% 1/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)
Infections and infestations Rotavirus infection	0.00% 0/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	1.3% 1/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)
Vascular disorders Kawasaki disease	0.00% 0/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	1.3% 1/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)
Infections and infestations Viral gastroenteritis	1.4% 1/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	0.00% 0/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)
Infections and infestations Pneumonia	1.4% 1/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	0.00% 0/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)
Cardiac disorders Cardio-respiratory Arrest	1.4% 1/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	0.00% 0/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)
Infections and infestations Gastroenteritis	1.4% 1/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	0.00% 0/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)

Other adverse events

Other adverse events
Measure	Subcutaneous Hylenex n=73 participants at risk Participants received isotonic fluid rehydration by subcutaneous administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]).	Intravenous Isotonic Fluid n=75 participants at risk Participants received isotonic fluid rehydration by intravenous injection.
General disorders Infusion site erythema	74.0% 54/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	25.3% 19/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)
General disorders Infusion site haematoma	0.00% 0/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	4.0% 3/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)
General disorders Infusion site oedema	6.8% 5/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	1.3% 1/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)
General disorders Infusion site pain	78.1% 57/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	78.7% 59/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)
General disorders Infusion site swelling	80.8% 59/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	21.3% 16/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)
General disorders Pyrexia	2.7% 2/73 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)	2.7% 2/75 Adverse event data are reported in members of the Safety Population, comprised of all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)

Additional Information

Dimitrios Chondros, M.D., Chief Medical Officer

Halozyme Therapeutics

Phone: 858-794-8889

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All information obtained as a result of this study or during the conduct of this study will be regarded as confidential. The Investigator agrees to use the information for the purpose of carrying out this study and for no other purpose, unless written permission from the sponsor (Halozyme) is obtained.
Publication restrictions are in place

Restriction type: OTHER