NCT01094548 · ADVERSE EVENTS

Adverse events

Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy · Source last updated 2016-02-22

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: From the first dose of study drug and up to 42 days after the last dose of study drug or clinical data cut-off date (07 March 2012)
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide \[L-BLP25\]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.	6 / 17	17 / 17	Not reported / Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m\^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.	5 / 17	17 / 17	Not reported / Not reported

Group identifiers: EG000: Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide · EG001: Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide

Serious 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
Cardiac disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
17
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Retinal detachment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Cholecystitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Arthritis bacterial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
17
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Wound infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Hypercalcaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Back pain

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
17
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Iron deficiency anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Sudden hearing loss
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
17
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Dacryostenosis acquired
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Dry eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Retinal detachment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Visual impairment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
8
num At Risk
17
term
Constipation

Complete source fields

event Groups

description
Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide \[L-BLP25\]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.
id
EG000
other Num Affected
17
other Num At Risk
17
serious Num Affected
6
serious Num At Risk
17
title
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
description
Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m\^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.
id
EG001
other Num Affected
17
other Num At Risk
17
serious Num Affected
5
serious Num At Risk
17
title
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
17
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Iron deficiency anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Sudden hearing loss
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
3
num At Risk
17
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Dacryostenosis acquired
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Dry eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Retinal detachment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Visual impairment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
8
num At Risk
17
term
Constipation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
17
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Retinal detachment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Cholecystitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Arthritis bacterial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
17
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Wound infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
17
term
Hypercalcaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA Version 13.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
17
term
Back pain

time Frame

From the first dose of study drug and up to 42 days after the last dose of study drug or clinical data cut-off date (07 March 2012)

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

Preserved source evidence · Not medical advice