Trial · NCT03292484
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study drug through 30 days after last dose of study drug, up to 59 months | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs | From first dose of study drug through 30 days after last dose of study drug, up to 59 months | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs | From first dose of study drug through 30 days after last dose of study drug, up to 59 months | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With TEAEs That Led to a Change in Treatment Regimen | From first dose of study drug through 30 days after last dose of study drug, up to 59 months | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With TEAEs That Led to Early Withdrawal | From first dose of study drug through 30 days after last dose of study drug, up to 59 months | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction | From first dose of study drug through 30 days after last dose of study drug, up to 59 months | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Use of Epinephrine as a Rescue Medication | From first dose of study drug through 30 days after last dose of study drug, up to 59 months | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes | From first dose of study drug through 30 days after last dose of study drug, up to 59 months | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods | From first dose of study drug through 30 days after last dose of study drug, up to 59 months | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Eosinophilic Esophagitis (EoE) | From first dose of study drug through 30 days after last dose of study drug, up to 59 months | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC) | OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58) | The safety population consisted of all participants who received AR101 during ARC008. Only those participants who had an OLFC or a DBPCFC are reported. | percentage of participants | NUMBER |
| SECONDARY | Maximum Tolerated Challenge Dose at Each Food Challenge | OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58) | The safety population consisted of all participants who received AR101 during ARC008. Only those participants who had an OLFC or a DBPCFC are reported. | mg | NUMBER |
| SECONDARY | Number of Participants With Use of Epinephrine as a Rescue Medication During the Food Challenges | OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58) | The safety population consisted of all participants who received AR101 during ARC008. Only those participants who had an OLFC or a DBPCFC are reported. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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