NCT00364923 · ADVERSE EVENTS

Adverse events

Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma · Source last updated 2019-12-19

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) were captured from the first dose of pralatrexate through 30 days after the last study treatment. From 31 days after the last dose of pralatrexate, pralatrexate-related AEs were recorded until the start of subsequent therapy.
Other-event reporting threshold: 5%

Serious AEs and AEs regardless of causality and all grades presented below. Symptoms present at baseline, AEs, and intercurrent illnesses were monitored at every study visit. Patients were instructed to report AEs to the investigator. All AEs including observed or volunteered problems, complaints, or symptoms were recorded.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Full Population All patients who received at least one dose of pralatrexate	50 / 111	111 / 111	Not reported / Not reported

Group identifiers: EG000: Full Population

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
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
5
num At Risk
111
term
sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
3
num At Risk
111
term
herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
3
num At Risk
111
term
pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
2
num At Risk
111
term
urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
candidiasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
catheter site infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
cytomegalovirus colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
wound infection

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 (11.0)
stats
group Id
EG000
num Affected
76
num At Risk
111
term
stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
45
num At Risk
111
term
nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
38
num At Risk
111
term
constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
28
num At Risk
111
term
vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
25
num At Risk
111
term
diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
12
num At Risk
111
term
abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
9
num At Risk
111
term
abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
7
num At Risk
111
term
gastroesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
6
num At Risk
111
term
flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
6
num At Risk
111
term
hemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
6
num At Risk
111
term
oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
38
num At Risk
111
term
fatigue

Complete source fields

description

event Groups

description
All patients who received at least one dose of pralatrexate
id
EG000
other Num Affected
111
other Num At Risk
111
serious Num Affected
50
serious Num At Risk
111
title
Full Population

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
76
num At Risk
111
term
stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
45
num At Risk
111
term
nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
38
num At Risk
111
term
constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
28
num At Risk
111
term
vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
25
num At Risk
111
term
diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
12
num At Risk
111
term
abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
9
num At Risk
111
term
abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
7
num At Risk
111
term
gastroesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
6
num At Risk
111
term
flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
6
num At Risk
111
term
hemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
6
num At Risk
111
term
oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
38
num At Risk
111
term
fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
5
num At Risk
111
term
sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
3
num At Risk
111
term
herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
3
num At Risk
111
term
pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
2
num At Risk
111
term
urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
candidiasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
catheter site infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
cytomegalovirus colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
111
term
wound infection

time Frame

All adverse events (AEs) were captured from the first dose of pralatrexate through 30 days after the last study treatment. From 31 days after the last dose of pralatrexate, pralatrexate-related AEs were recorded until the start of subsequent therapy.

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Preserved source evidence · Not medical advice