Trial Outcomes & Findings for Evaluation of Skin Testing Reagents for Penicillin Allergy (NCT NCT01818336)

Last Updated: 2017-01-04

Results Overview

The primary endpoint was the negative predictive value (NPV), which was estimated as p = percentage of n history-positive subjects with negative skin tests from the Penicillin Allergy Skin Test Kit (as confirmed with an overall negative result for the skin puncture/intradermal testing) who do not experience an IgE-dependent hypersensitivity reaction within 72 hours of the oral amoxicillin challenge.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

481 participants

Primary outcome timeframe

72 hours

Results posted on

2017-01-04

Participant Flow

This was a prospective, open-label investigation of skin testing with the Penicillin Skin Test Kit conducted at 13 asthma and allergy centers in the United States.

455 History pos subj enrolled + 2 control subj @ 13 centers. All 481 subj were skin tested(ST) and included in safety population. 64 subj (all history pos) had pos or discordant skin tests and were excluded from ITT population of 391(455 - 64). The subset of 59 ST pos subjects were invited back at 4 weeks for repeat ST; 47 ST pos subj returned

Participant milestones

Participant milestones
Measure	Intent-to-Treat Population All subjects who had valid skin testing performed (i.e., administered all components of the Penicillin Skin Test Kit and the histamine and control results were valid) and who received the oral amoxicillin challenge.	Subjects in Retest Population All subjects who initially tested positive to any of the initial skin tests with penicillin reagents and subsequently returned after 4 weeks for retesting.
Overall Study STARTED	391	59
Overall Study COMPLETED	391	47
Overall Study NOT COMPLETED	0	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Intent-to-Treat Population All subjects who had valid skin testing performed (i.e., administered all components of the Penicillin Skin Test Kit and the histamine and control results were valid) and who received the oral amoxicillin challenge.	Subjects in Retest Population All subjects who initially tested positive to any of the initial skin tests with penicillin reagents and subsequently returned after 4 weeks for retesting.
Overall Study Declined retest visit	0	11
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Safety population is equal to all enrolled subjects. ITT, Per-protocol, and Re-skin tested subpopulations have been defined elsewhere.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Population n=481 Participants All subjects who had skin testing performed (i.e., administered any component of the Penicillin Skin Test Kit).
Age, Continuous Safety Population	49.4 years STANDARD_DEVIATION 16.34 • n=481 Participants • Safety population is equal to all enrolled subjects. ITT, Per-protocol, and Re-skin tested subpopulations have been defined elsewhere.
Age, Continuous Intent-to-Treat Population	50.2 years STANDARD_DEVIATION 16.40 • n=391 Participants • Safety population is equal to all enrolled subjects. ITT, Per-protocol, and Re-skin tested subpopulations have been defined elsewhere.
Age, Continuous Per-Protocol Population	50.2 years STANDARD_DEVIATION 16.49 • n=373 Participants • Safety population is equal to all enrolled subjects. ITT, Per-protocol, and Re-skin tested subpopulations have been defined elsewhere.
Age, Continuous Retest Population	50.5 years STANDARD_DEVIATION 15.32 • n=59 Participants • Safety population is equal to all enrolled subjects. ITT, Per-protocol, and Re-skin tested subpopulations have been defined elsewhere.
Gender Female	138 Participants n=481 Participants
Gender Male	343 Participants n=481 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=481 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	467 Participants n=481 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=481 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=481 Participants
Race (NIH/OMB) Asian	6 Participants n=481 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=481 Participants
Race (NIH/OMB) Black or African American	16 Participants n=481 Participants
Race (NIH/OMB) White	440 Participants n=481 Participants
Race (NIH/OMB) More than one race	0 Participants n=481 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=481 Participants
Region of Enrollment United States	481 participants n=481 Participants
Penicillin allergy history No	26 participants n=481 Participants
Penicillin allergy history Yes	455 participants n=481 Participants
Previous penicillin testing history No	464 participants n=481 Participants
Previous penicillin testing history Yes	17 participants n=481 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: The Intent-to-Treat Population; all subjects with valid skin testing performed (ie, administered all components of the penicillin skin test kit and the histamine/control results were valid), who had negative intradermal skin tests with all 3 Kit reagents, and who received the oral amoxicillin challenge

Outcome measures

Outcome measures
Measure	Intent-to-Treat Population n=391 Participants All subjects who had valid skin testing performed (i.e., administered all components of the Penicillin Skin Test Kit and the histamine control results are valid) and who receive the oral amoxicillin challenge.
Negative Predictive Value	98.0 percentage of participants Interval 96.6 to 99.4

Adverse Events

Safety Population-All Study-Emergent Adverse Events

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Subjects With AE Related to Skin Testing

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Subjects With AE Related to Oral Amox Challenge

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Franklin Adkinson Jr., MD-Vice President, Chief Medical Officer

AllerQuest

Phone: 410-550-2051

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Safety Population-All Study-Emergent Adverse Events n=481 participants at risk Intervention: Penicillin skin test kit The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s). Subjects who had negative puncture and intradermal test results were given the oral amoxicillin challenge, which was comprised of a single, age-dependent, full oral dose of amoxicillin. The purpose of the oral amoxicillin challenge was to confirm absence of allergy and confirm the NPV of skin testing. Subjects were monitored at the study site for 1 hour following oral amoxicillin challenge and then sent home. The study site followed up by telephone with all subjects ≥72 hours after administration of the oral amoxicillin challenge.	Subjects With AE Related to Skin Testing n=481 participants at risk Intervention: Penicillin skin test kit The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s).	Subjects With AE Related to Oral Amox Challenge n=391 participants at risk Intervention: Penicillin skin test kit The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s). Subjects who had negative puncture and intradermal test results were given the oral amoxicillin challenge, which was comprised of a single, age-dependent, full oral dose of amoxicillin. The purpose of the oral amoxicillin challenge was to confirm absence of allergy and confirm the NPV of skin testing. Subjects were monitored at the study site for 1 hour following oral amoxicillin challenge and then sent home. The study site followed up by telephone with all subjects ≥72 hours after administration of the oral amoxicillin challenge.
Skin and subcutaneous tissue disorders Pruritus	3.1% 15/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.42% 2/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.51% 2/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Skin and subcutaneous tissue disorders Rash	1.2% 6/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.51% 2/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Skin and subcutaneous tissue disorders Post-procedural hematoma	1.0% 5/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.62% 3/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Skin and subcutaneous tissue disorders Erythema	0.83% 4/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.51% 2/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Gastrointestinal disorders Diarrhea	0.83% 4/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.51% 2/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Gastrointestinal disorders Abdominal discomfort	0.62% 3/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.51% 2/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
General disorders Chest discomfort	0.62% 3/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.62% 3/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Vascular disorders Flushing	0.62% 3/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.51% 2/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Nervous system disorders Headache	0.42% 2/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Skin and subcutaneous tissue disorders Pruritus generalised	0.42% 2/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Skin and subcutaneous tissue disorders Rash pruritic	0.42% 2/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Immune system disorders Urticaria	0.42% 2/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Skin and subcutaneous tissue disorders Dermatitis	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Skin and subcutaneous tissue disorders Rash erythematous	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Skin and subcutaneous tissue disorders Rash macular	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Skin and subcutaneous tissue disorders Skin disorder	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Gastrointestinal disorders Abdominal pain upper	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Gastrointestinal disorders Vomiting	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
General disorders Chills	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
General disorders Oedema peripheral	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
General disorders Pain	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Immune system disorders Angiodema	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Musculoskeletal and connective tissue disorders Joint stiffness	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.21% 1/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.00% 0/481 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.	0.26% 1/391 • Adverse events were recorded immediately following administration of the Penicillin Skin Test and throughout the 3-day study period as spontaneously reported by subjects, reported during the phone interview ≥72-hours post-oral challenge, or observed by the site staff.