NCT02043860 · ADVERSE EVENTS

Adverse events

Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma · Source last updated 2019-10-14

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: 2 years
Other-event reporting threshold: 1%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1 TMI Dose 3Gy This is a phase I trial. Patients will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). The dose of TMI will increase until the maximum tolerated dose (MTD) is reached. 3 participants will be in each cohort beginning with the lowest possible dose of 3Gy to a maximum dose of 12Gy. All Cause Mortality Total 0/2 0% Serious Adverse Events Total 0/2 0% Adverse Events not including serious adverse events Total 2/2 100% Oral Mucositis 2/2 100% Diarrhea 2/2 100% Nausea 1/2 50% Non-productive cough 1/2 50% Rash to face and back 1/2 50% Throat pain 1/2 50% GI bleed 1/2 50%	0 / 2	2 / 2	0 / 2

Group identifiers: EG000: Cohort 1 TMI Dose 3Gy

Serious adverse events

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

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
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
GI bleed
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Throat pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Rash to face and back
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Non-productive cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Shortness of breath on exertion

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
2
description
This is a phase I trial. Patients will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). The dose of TMI will increase until the maximum tolerated dose (MTD) is reached. 3 participants will be in each cohort beginning with the lowest possible dose of 3Gy to a maximum dose of 12Gy. All Cause Mortality Total 0/2 0% Serious Adverse Events Total 0/2 0% Adverse Events not including serious adverse events Total 2/2 100% Oral Mucositis 2/2 100% Diarrhea 2/2 100% Nausea 1/2 50% Non-productive cough 1/2 50% Rash to face and back 1/2 50% Throat pain 1/2 50% GI bleed 1/2 50%
id
EG000
other Num Affected
2
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Cohort 1 TMI Dose 3Gy

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
GI bleed
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Throat pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Rash to face and back
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Non-productive cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Shortness of breath on exertion

time Frame

2 years

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Preserved source evidence · Not medical advice