The Effect of Antihypertensive Drugs on Severity of Anaph... | NCT04269629

The Effect of Antihypertensive Drugs on Severity of Anaph... | NCT04269629 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with a history of an anaphylactic sting reaction		At Visit 1, patients will be included after carefully reviewing all inclusion and exclusion criteria. All data concerning the index sting, laboratory parameters like immunoglobulin E (IgE) and tryptase levels and skin test results will be recorded as well as the concomitant diseases and medication. Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reactions (LLR) and systemic reactions (SR) and changes in diseases and medication will be recorded. One year after reaching the maintenance dose, Visit 3 will be performed. At this Visit data concerning the maintenance phase like premedication and possible side effects will be recorded as well as the outcome of insect stings.	Drug: Insect Venom

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insect Venom	Drug	Patients receive insect venom immunotherapy. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT)	The primary objective of this study is to evaluate whether subjects under antihypertensive treatment with beta-blockers and/or angiotensin converting enzyme (ACE)-inhibitors show more side effects during VIT compared to subjects with no antihypertensive treatment.	after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour

Secondary Outcomes

Measure	Description	Time Frame
Severity of Sting Reactions	To evaluate whether subjects under antihypertensive treatment with beta-blockers and/or ACE-inhibitors have more severe sting reactions.	duration of first visit (~1hour)
Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Severe Systemic Sting Reactions.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology and Venerology, Medical University of Graz		Graz		8036	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33605465	Derived	Sturm GJ, Herzog SA, Aberer W, Alfaya Arias T, Antolin-Amerigo D, Bonadonna P, Boni E, Bozek A, Chelminska M, Ernst B, Frelih N, Gawlik R, Gelincik A, Hawranek T, Hoetzenecker W, Jimenez Blanco A, Kita K, Kendirlinan R, Kosnik M, Laipold K, Lang R, Marchi F, Mauro M, Nittner-Marszalska M, Poziomkowska-Gesicka I, Pravettoni V, Preziosi D, Quercia O, Reider N, Rosiek-Biegus M, Ruiz-Leon B, Schrautzer C, Serrano P, Sin A, Sin BA, Stoevesandt J, Trautmann A, Vachova M, Arzt-Gradwohl L. beta-blockers and ACE inhibitors are not a risk factor for severe systemic sting reactions and adverse events during venom immunotherapy. Allergy. 2021 Jul;76(7):2166-2176. doi: 10.1111/all.14785. Epub 2021 Mar 11.

Arm/Group Information

ID	Title	Description
FG000	Patients With a History of an Anaphylactic Sting Reaction	At Visit 1, patients will be included after carefully reviewing all inclusion and exclusion criteria. All data concerning the index sting, laboratory parameters like IgE and tryptase levels and skin test results will be recorded as well as the concomitant diseases and medication. Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reactions and SR and changes in diseases and medication will be recorded. One year after reaching the maintenance dose, Visit 3 will be performed. At this Visit data concerning the maintenance phase like premedication and possible side effects will be recorded as well as the outcome of insect stings. Insect Venom: Patients receive insect venom immunotherapy. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0001425 subjects1425 patients were included in the study (=Visit 1)
Number of Patients Who Performed VIT		FG0001342 subjectsVisit 2 was performed with 1342 patients
COMPLETED		FG0001186 subjectsVisit 3 was performed with 1186 patients
NOT COMPLETED		FG000239 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Patients With a History of an Anaphylactic Sting Reaction	At Visit 1, patients will be included after carefully reviewing all inclusion and exclusion criteria. All data concerning the index sting, laboratory parameters like IgE and tryptase levels and skin test results will be recorded as well as the concomitant diseases and medication. Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reaction and SR and changes in diseases and medication will be recorded. One year after reaching the maintenance dose, Visit 3 will be performed. At this Visit data concerning the maintenance phase like premedication and possible side effects will be recorded as well as the outcome of insect stings. Insect Venom: Patients receive insect venom immunotherapy. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT)

The primary objective of this study is to evaluate whether subjects under antihypertensive treatment with beta-blockers and/or angiotensin converting enzyme (ACE)-inhibitors show more side effects during VIT compared to subjects with no antihypertensive treatment.

1342 patients underwent VIT and performed Visit 2. Of these 1342 patients, 93 experienced a systemic side effect during the updosing phase of VIT. Data were missing for 10 participants.

Posted

Count of Participants

Participants

after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour

ID	Title	Description
OG000	Patients Who Underwent VIT Updosing	Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reactions and SR and changes in diseases and medication will be recorded. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Patients With a History of an Anaphylactic Sting Reaction	At Visit 1, patients will be included after carefully reviewing all inclusion and exclusion criteria. All data concerning the index sting, laboratory parameters like IgE and tryptase levels and skin test results will be recorded as well as the concomitant diseases and medication. Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reaction and SR and changes in diseases and medication will be recorded. One year after reaching the maintenance dose, Visit 3 will be performed. At this Visit data concerning the maintenance phase like premedication and possible side effects will be recorded as well as the outcome of insect stings. Insect Venom: Patients receive insect venom immunotherapy. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Assoz.-Prof. Dr. Gunter Sturm	Department of Dermatology and Venerology	+4331638580318		gunter.sturm@medunigraz.at

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 4, 2018	Jul 15, 2020	Prot_SAP_000.pdf

Intervention Browse Module

ID	Term
D001180	Arthropod Venoms

ID	Term
D014688	Venoms
D045424	Complex Mixtures
D014118	Toxins, Biological
D001685	Biological Factors

Title

Denominators

Categories

number of patients with SR with AHT treatment

- ParticipantsOG000338

Title	Measurements
	OG00019

number of patients with SR without AHT treatment

- ParticipantsOG000994

Title	Measurements
	OG00074

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	It was assumed that 24% of the patients would be on β-blockers and/or ACE inhibitors (ACEI). A χ2 test with a two-sided 5% significance level has an 80% power to detect the difference between the group without antihypertensive medication with 6% SR during VIT and the group on β-blockers and/or ACEI with 12.3% SR during VIT (OR = 2.2) when the sample sizes are 631 and 200, respectively. A drop-out rate of 37% was assumed which resulted in a required number of 1,319 patients.	Mixed Models Analysis	Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.	0.25	The level of significance was set at 0.05.													Other	All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACEI) and the group without such treatment. The primary outcome was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.

Secondary

Severity of Sting Reactions

To evaluate whether subjects under antihypertensive treatment with beta-blockers and/or ACE-inhibitors have more severe sting reactions.

1425 patients were included in the study at Visit 1. Of these 1425 patients, 603 initially experienced a severe (=Grade 3 and 4 according to the classification of Ring and Messmer), systemic sting reaction. Data were missing for 2 participants.

Posted

Count of Participants

Participants

duration of first visit (~1hour)

ID	Title	Description
OG000	Patients With a History of an Anaphylactic Sting Reaction	At Visit 1, patients will be included after carefully reviewing all inclusion and exclusion criteria. All data concerning the index sting, laboratory parameters like IgE and tryptase levels and skin test results will be recorded as well as the concomitant diseases and medication. The severity of the systemic sting reaction is compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

Units	Counts
Participants	OG0001423

Title

Denominators

Categories

severe reactions in patients with AHT treatment

- ParticipantsOG000388

Title	Measurements
	OG000171

severe reactions in patients without AHT treatment

- ParticipantsOG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		Mixed Models Analysis	Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.	0.29	The level of significance was set at 0.05.													Other	All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.

Secondary

Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Severe Systemic Sting Reactions.

To correlate the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions.

Correlation cardiovascular disease with risk of more severe systemic sting reaction: 601 of 1425 patients (Visit 1) experienced a severe systemic sting reaction. Datasets missing:9

Posted

Count of Participants

Participants

duration of first visit (~1hour)

ID	Title	Description
OG000	Patients With Anaphylactic Sting Reaction	At Visit 1, patients will be included after carefully reviewing all inclusion and exclusion criteria. All data concerning the index sting, laboratory parameters like IgE and tryptase levels and skin test results will be recorded as well as the concomitant diseases and medication.

Units	Counts
Participants	OG0001416

Title

Denominators

Categories

severe sting reaction, cardiovascular disease

- ParticipantsOG000571

Title	Measurements
	OG000258

severe sting reaction, no cardiovascular disease

- ParticipantsOG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Analysis for correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions.	Mixed Models Analysis	Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.	0.04	The level of significance was set at 0.05. Correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions (p=0.04).													Other

Secondary

Association of Bee Venom With a Higher Frequency of Side-effects (=Systemic Reaction, SR).

To evaluate whether bee venom is associated with a higher frequency of side-effects.

1342 patients underwent VIT and performed Visit 2. Of these 1342 patients, 93 experienced a systemic side effect during the updosing phase of VIT. Data missing for 10 participants.

Posted

Count of Participants

Participants

after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour

ID	Title	Description
OG000	Patients Who Underwent VIT Updosing	Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reaction and SR and changes in diseases and medication will be recorded. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

Units	Counts
Participants	OG0001332

Title

Denominators

Categories

SR in patients treated with bee venom

- ParticipantsOG000414

Title	Measurements
	OG00054

SR in patients treated with vespid venom

- ParticipantsOG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		Mixed Models Analysis	Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.	<0.001	The level of significance was set at 0.05.													Other	All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.

Secondary

Correlation of High Specific Immunoglobulin E (sIgE) Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).

To evaluate whether high specific immunoglobulin E (sIgE) levels are correlated to a higher frequency of side-effects.

sIgE levels are expressed in kilo units/liter [kU/L].

1342 patients underwent VIT and performed Visit 2. Of these 1342 patients, 93 experienced a systemic side effect during the updosing phase of VIT. sIgE levels were only available for 1009 patients, the other data (=333) are missing.

Posted

Count of Participants

Participants

after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour

ID	Title	Description
OG000	Patients Who Underwent VIT Updosing	Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reaction and SR and changes in diseases and medication will be recorded. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

Units	Counts
Participants	OG0001009

Title

Denominators

Categories

SR, bee venom, IgE >0.35-3.5 kU/L

- ParticipantsOG000113

Title	Measurements
	OG00017

SR, bee venom, IgE >3.5-17.5 kU/L

- ParticipantsOG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Analysis for sIgE levels - bee venom.	Mixed Models Analysis	Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.	0.99	The level of significance was set at 0.05.													Other	All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.

Secondary

Correlation of High Tryptase Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).

To evaluate whether high tryptase levels are correlated to a higher frequency of side-effects

1342 patients underwent VIT and performed Visit 2. Of these 1342 patients, 93 experienced a systemic side effect during the updosing phase of VIT. Tryptase levels were only available for 1204 patients. Data missing for 138 participants.

Posted

Count of Participants

Participants

after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour

ID	Title	Description
OG000	Patients Who Underwent VIT Updosing	Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reaction and SR and changes in diseases and medication will be recorded. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

Units	Counts
Participants	OG0001204

Title

Denominators

Categories

SR in patients with tryptase <11.4µg/L

- ParticipantsOG0001084

Title	Measurements
	OG00074

SR in patients with tryptase >11.4µg/L

- ParticipantsOG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		Mixed Models Analysis	Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.	0.16	The level of significance was set at 0.05.													Other	All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.

Secondary

Correlation of Quicker Up-dosing Protocols to a Higher Frequency of Side-effects (=Systemic Reaction, SR).

To evaluate whether quicker up-dosing protocols are correlated to a higher frequency of side-effects.

1342 patients underwent VIT and performed Visit 2. Of these 1342 patients, 93 experienced a systemic side effect during the updosing phase of VIT. Data concerning the updosing protocol used were available for 1321 patients; data missing for 21 participants.

Posted

Count of Participants

Participants

depends on the protocol used for venom immunotherapy, a maximum of about 6 months

ID	Title	Description
OG000	Patients Who Underwent VIT Updosing	Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reaction and SR and changes in diseases and medication will be recorded. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

Units	Counts
Participants	OG0001321

Title

Denominators

Categories

SR in patients with conventional updosing

- ParticipantsOG000109

Title	Measurements
	OG0005

SR in patients with quicker updosing

- ParticipantsOG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		Mixed Models Analysis	Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.	0.50	The level of significance was set at 0.05.													Other	All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.

Secondary

Efficacy of VIT

The outcome (systemic reaction to sting or not) of sting challenges and/or field stings will be recorded to identify patients who will not tolerate but react to future stings. These results will be compared between patients not taking antihypertensive (AHT) drugs and patients taking AHT drugs.

Visit 3 was performed with 1186 patients one year after reaching the maintenance phase of VIT. Data missing for 4 participants.

Posted

Count of Participants

Participants

1 year after reaching the maintenance dose; duration of Visit ~1hour

ID	Title	Description
OG000	Patients Who Underwent VIT for at Least 1 Year	One year after reaching the maintenance dose, Visit 3 will be performed. At this Visit data concerning the maintenance phase like premedication and possible side effects will be recorded as well as the outcome of insect stings. The outcome (systemic reaction or not) of insect stings is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

Units	Counts
Participants	OG0001182

Title

Denominators

Categories

SR after sting, AHT treatment

- ParticipantsOG000296

Title	Measurements
	OG0004

SR after sting, no AHT treatment

- ParticipantsOG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		Fisher Exact		0.72	The level of significance was set at 0.05.													Other

Secondary

Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Frequent Side Effects (=Systemic Reaction, SR) Under VIT.

To correlate the prevalence of cardiovascular diseases and/or hypertension with the risk for more frequent side effects (=systemic reaction, SR) under VIT..

Correlation cardiovascular disease with risk of more frequent side effects under VIT: 93 of 1342 patients (Visit 2) experienced a SR. Datasets missing:17

Posted

Count of Participants

Participants

duration of Visit ~1hour

ID	Title	Description
OG000	Patients Who Underwent VIT Updosing	Visit 2 will be performed after VIT updosing is finished. At this Visit data concerning the immunotherapy - premedication, preparation, updosing protocol, the outcome of possible large, local reaction and SR and changes in diseases and medication will be recorded. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

Units	Counts
Participants	OG0001325

Title

Denominators

Categories

systemic side-effect, cardiovascular disease

- ParticipantsOG000528

Title	Measurements
	OG00030

systemic side-effect, no cardiovascular disease

- ParticipantsOG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Analysis for correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more frequent SR under VIT.	Mixed Models Analysis	Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.	0.11	The level of significance was set at 0.05.													Other	All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitor) and the group without such treatment. The secondary outcomes were analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.