NCT02716805 · ADVERSE EVENTS

Adverse events

Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant · Source last updated 2022-10-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 14 months.
Other-event reporting threshold: 0%

AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to the indicated study drug; preferred terms were counted only once per subject at the maximum reported grade.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1 "Late" post-ASCT treatment (tremelimumab alone in Cycles 1-2, durvalumab alone in Cycles 3+)	1 / 6	6 / 6	0 / 6

Group identifiers: EG000: Cohort 1

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Hypercalcaemia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
5
num At Risk
6
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Blood blister
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Influenza like illness

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
6
description
"Late" post-ASCT treatment (tremelimumab alone in Cycles 1-2, durvalumab alone in Cycles 3+)
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
Cohort 1

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
5
num At Risk
6
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Blood blister
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Influenza like illness

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
term
Hypercalcaemia

time Frame

All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 14 months.

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Preserved source evidence · Not medical advice