NCT01420679 · ADVERSE EVENTS

Adverse events

Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients · Source last updated 2021-11-19

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: From first dose of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years)
Other-event reporting threshold: 5%

Safety population included all randomized participants classified according to the actual study treatment received, regardless of random assignment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pralatrexate Arm Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \[NaCl\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\^2), could be reduced to 20 mg/m\^2 with potential further reductions to 15 and 10 mg/m\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.	4 / 14	14 / 14	3 / 14
Observation Arm Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.	0 / 7	6 / 7	1 / 7

Group identifiers: EG000: Pralatrexate Arm · EG001: Observation Arm

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
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Subdural hematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Hyponatraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Haemorrhage intracranial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Carotid artery occlusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
VIIth nerve paralysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Confusional state
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Dyspnoea

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
1
num At Risk
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
2
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
14
group Id
EG001
num Affected
1
num At Risk
7
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Aphthous stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
14
group Id
EG001
num Affected
1
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
6
num At Risk
14
group Id
EG001
num Affected
1
num At Risk
7
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Haematochezia

Complete source fields

description

Safety population included all randomized participants classified according to the actual study treatment received, regardless of random assignment.

event Groups

deaths Num Affected
3
deaths Num At Risk
14
description
Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \[NaCl\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\^2), could be reduced to 20 mg/m\^2 with potential further reductions to 15 and 10 mg/m\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
id
EG000
other Num Affected
14
other Num At Risk
14
serious Num Affected
4
serious Num At Risk
14
title
Pralatrexate Arm
deaths Num Affected
1
deaths Num At Risk
7
description
Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
id
EG001
other Num Affected
6
other Num At Risk
7
serious Num Affected
0
serious Num At Risk
7
title
Observation Arm

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
1
num At Risk
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
2
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
14
group Id
EG001
num Affected
1
num At Risk
7
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Aphthous stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
14
group Id
EG001
num Affected
1
num At Risk
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
6
num At Risk
14
group Id
EG001
num Affected
1
num At Risk
7
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
3
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Haematochezia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Subdural hematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Hyponatraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Haemorrhage intracranial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Carotid artery occlusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
VIIth nerve paralysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Confusional state
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 17.0
stats
group Id
EG000
num Affected
1
num At Risk
14
group Id
EG001
num Affected
0
num At Risk
7
term
Dyspnoea

time Frame

From first dose of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years)

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Preserved source evidence · Not medical advice