Trial · NCT01100502

A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)

NCT01100502, Phase 3, Completed, Seagen Inc.; results first posted 2015-11-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial). Trials, record NCT01100502. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01100502

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)
NCT number: NCT01100502
Status: Completed
Phases: Phase 3
Enrollment: 329 participants, actual
Lead sponsor: Seagen Inc.
Conditions: Disease, Hodgkin
Interventions: brentuximab vedotin, placebo
First posted: 2010-04-09
Last updated: 2021-05-14
Other registries' IDs: eudract:2009-016947-20
Results first posted: 2015-11-11

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival by Independent Review	Up to approximately 4 years	Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first
Secondary	Overall Survival	Up to approximately 10 years	Time from date of randomization to date of death due to any cause
Secondary	Incidence of Adverse Events or Laboratory Abnormalities	Up to 12 months
Secondary	Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin	Up to 12 months

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival by Independent Review	Up to approximately 4 years	Intention-to-Treat analysis set	months	MEDIAN
SECONDARY	Overall Survival	Up to approximately 10 years	Intention-to-Treat analysis set	months	MEDIAN
SECONDARY	Incidence of Adverse Events or Laboratory Abnormalities	Up to 12 months	Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis	participants	NUMBER
SECONDARY	Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin	Up to 12 months	ATA-evaluable patients (patients with a baseline and at least 1 postbaseline sample)	participants	NUMBER

Source ClinicalTrials.gov

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival by Independent Review	Brentuximab Vedotin		42.9	95% Confidence Interval 30.4 to 42.9	months
Progression-free Survival by Independent Review	Placebo		24.1	95% Confidence Interval 11.5 to NA	months
Overall Survival	Brentuximab Vedotin		NA	Full Range 1.31 to 117.88	months
Overall Survival	Placebo		NA	Full Range 0.03 to 119.23	months
Incidence of Adverse Events or Laboratory Abnormalities	Brentuximab Vedotin	Any Treatment-Emergent Adverse Event	163		participants
Incidence of Adverse Events or Laboratory Abnormalities	Placebo	Any Treatment-Emergent Adverse Event	142		participants
Incidence of Adverse Events or Laboratory Abnormalities	Brentuximab Vedotin	Any Treatment-Related Adverse Event	147		participants
Incidence of Adverse Events or Laboratory Abnormalities	Placebo	Any Treatment-Related Adverse Event	79		participants
Incidence of Adverse Events or Laboratory Abnormalities	Brentuximab Vedotin	Any Adverse Event with Severity >= Grade 3	93		participants
Incidence of Adverse Events or Laboratory Abnormalities	Placebo	Any Adverse Event with Severity >= Grade 3	51		participants

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Brentuximab Vedotin	165
Overall Study	STARTED	Placebo	164
Overall Study	COMPLETED	Brentuximab Vedotin	89
Overall Study	COMPLETED	Placebo	70
Overall Study	NOT COMPLETED	Brentuximab Vedotin	76
Overall Study	NOT COMPLETED	Placebo	94

Source ClinicalTrials.gov

Adverse events224

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Placebo	4	160
other	Anaemia	Blood and lymphatic system disorders	Brentuximab Vedotin	14	167
other	Leukopenia	Blood and lymphatic system disorders	Placebo	3	160
other	Leukopenia	Blood and lymphatic system disorders	Brentuximab Vedotin	9	167
other	Neutropenia	Blood and lymphatic system disorders	Placebo	18	160
other	Neutropenia	Blood and lymphatic system disorders	Brentuximab Vedotin	58	167
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	3	160
other	Thrombocytopenia	Blood and lymphatic system disorders	Brentuximab Vedotin	12	167
other	Sinus tachycardia	Cardiac disorders	Placebo	3	160
other	Sinus tachycardia	Cardiac disorders	Brentuximab Vedotin	9	167

1 to 10 of 224Source ClinicalTrials.gov

See all 224 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	40	160
Total, all-cause mortality	Brentuximab Vedotin	45	167
Total, other adverse events	Placebo	127	160
Total, other adverse events	Brentuximab Vedotin	151	167
Total, serious adverse events	Placebo	21	160
Total, serious adverse events	Brentuximab Vedotin	43	167

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25796459	RESULT	PubMed
30266774	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Brentuximab Vedotin vs Placebo: deaths from any cause	Trial comparisons
Brentuximab Vedotin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01100502

GET https://conductscience.org/api/trials/v1/NCT01100502/results?page=2

API reference For AI assistants