NCT01849848 · ADVERSE EVENTS

Adverse events

Study of SyB L-0501 to Treat Relapsed/Refractory Multiple Myeloma · Source last updated 2015-02-06

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 around 44 weeks
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
SyB L-0501 SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.	4 / 17	17 / 17	Not reported / Not reported

Group identifiers: EG000: SyB L-0501

Serious adverse events

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

organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Plasma cell myeloma
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Arthralgia
organ System
Infections and infestations
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Pneumonia
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Constipation

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 Ver 16.0
stats
group Id
EG000
num Affected
7
num At Risk
17
term
Anaemia
organ System
Eye disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Conjunctivitis
organ System
Eye disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Dry eye
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Abdominal pain
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
5
num At Risk
17
term
Constipation
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Dental caries
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
3
num At Risk
17
term
Diarrhoea
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Haemorrhoids
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
8
num At Risk
17
term
Nausea
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Proctalgia
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Stomatitis
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
2
num At Risk
17
term
Vomiting

Complete source fields

event Groups

description
SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
id
EG000
other Num Affected
17
other Num At Risk
17
serious Num Affected
4
serious Num At Risk
17
title
SyB L-0501

frequency Threshold

other Events

organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
7
num At Risk
17
term
Anaemia
organ System
Eye disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Conjunctivitis
organ System
Eye disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Dry eye
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Abdominal pain
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
5
num At Risk
17
term
Constipation
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Dental caries
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
3
num At Risk
17
term
Diarrhoea
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Haemorrhoids
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
8
num At Risk
17
term
Nausea
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Proctalgia
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Stomatitis
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
2
num At Risk
17
term
Vomiting

serious Events

organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Plasma cell myeloma
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Arthralgia
organ System
Infections and infestations
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Pneumonia
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Ver 16.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Constipation

time Frame

up to around 44 weeks

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

Preserved source evidence · Not medical advice