NCT04843007 · ADVERSE EVENTS

Adverse events

Alvopem® (Pemetrexed) Safety Assessment · Source last updated 2024-10-23

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: Three years and half
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
NanoAlvand Pemetrexed 500 mg/m\^2 pemetrexed, IV infusion Pemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2	50 / 198	190 / 198	28 / 198

Group identifiers: EG000: NanoAlvand Pemetrexed

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
50
num At Risk
198
term
Anaemia

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 4.0 Beta
stats
group Id
EG000
num Affected
177
num At Risk
198
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
49
num At Risk
198
term
leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
57
num At Risk
198
term
neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
20
num At Risk
198
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
20
num At Risk
198
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
12
num At Risk
198
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
48
num At Risk
198
term
Creatinine renal clearance decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
1
num At Risk
198
term
Renal disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
1
num At Risk
198
term
Drug intolerance

Complete source fields

event Groups

deaths Num Affected
28
deaths Num At Risk
198
description
500 mg/m\^2 pemetrexed, IV infusion Pemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2
id
EG000
other Num Affected
190
other Num At Risk
198
serious Num Affected
50
serious Num At Risk
198
title
NanoAlvand Pemetrexed

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
177
num At Risk
198
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
49
num At Risk
198
term
leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
57
num At Risk
198
term
neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
20
num At Risk
198
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
20
num At Risk
198
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
12
num At Risk
198
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
48
num At Risk
198
term
Creatinine renal clearance decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
1
num At Risk
198
term
Renal disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
1
num At Risk
198
term
Drug intolerance

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 4.0 Beta
stats
group Id
EG000
num Affected
50
num At Risk
198
term
Anaemia

time Frame

Three years and half

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Preserved source evidence · Not medical advice