NCT01179490 · ADVERSE EVENTS

Adverse events

Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma · Source last updated 2013-03-18

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: Up to 2 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
SyB L-0501 + Prednisolone SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.	2 / 5	5 / 5	Not reported / Not reported

Group identifiers: EG000: SyB L-0501 + Prednisolone

Serious adverse events

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

organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Pneumonia
organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Septic shock
organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Pneumonia bacterial
organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Acute respiratory distress syndrome

Other reported adverse events

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

organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Anaemia
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Febrile neutropenia
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Abdominal distension
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Constipation
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Diarrhoea
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
3
num At Risk
5
term
Nausea
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Proctalgia
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Stomatitis
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Vomiting
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Malaise
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Oedema
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Oedema peripheral

Complete source fields

event Groups

description
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
id
EG000
other Num Affected
5
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
SyB L-0501 + Prednisolone

frequency Threshold

other Events

organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Anaemia
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Febrile neutropenia
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Abdominal distension
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Constipation
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Diarrhoea
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
3
num At Risk
5
term
Nausea
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Proctalgia
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Stomatitis
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Vomiting
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Malaise
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Oedema
organ System
General disorders
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Oedema peripheral

serious Events

organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Pneumonia
organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Septic shock
organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Pneumonia bacterial
organ System
Infections and infestations
source Vocabulary
MedDRA (14.1)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Acute respiratory distress syndrome

time Frame

Up to 2 years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice