NCT02653976 · ADVERSE EVENTS

Adverse events

A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) · Source last updated 2024-01-26

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 date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
SP-02L (Darinaparsin for Injection) SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days	30 / 65	64 / 65	6 / 65

Group identifiers: EG000: SP-02L (Darinaparsin for Injection)

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
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
7
num At Risk
65
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
5
num At Risk
65
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Hypothermia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Multiple organ dysfunction syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
65
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Lymphadenitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Biliary fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Anaphylactic shock

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 23.0
stats
group Id
EG000
num Affected
16
num At Risk
65
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
14
num At Risk
65
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
11
num At Risk
65
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
7
num At Risk
65
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
7
num At Risk
65
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
12
num At Risk
65
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
7
num At Risk
65
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
6
num At Risk
65
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
5
num At Risk
65
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
24
num At Risk
65
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
9
num At Risk
65
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
6
num At Risk
65
term
Fatigue

Complete source fields

event Groups

deaths Num Affected
6
deaths Num At Risk
65
description
SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
id
EG000
other Num Affected
64
other Num At Risk
65
serious Num Affected
30
serious Num At Risk
65
title
SP-02L (Darinaparsin for Injection)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
16
num At Risk
65
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
14
num At Risk
65
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
11
num At Risk
65
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
7
num At Risk
65
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
7
num At Risk
65
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
12
num At Risk
65
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
7
num At Risk
65
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
6
num At Risk
65
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
5
num At Risk
65
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
24
num At Risk
65
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
9
num At Risk
65
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
6
num At Risk
65
term
Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
7
num At Risk
65
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
5
num At Risk
65
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Hypothermia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Multiple organ dysfunction syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
65
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Lymphadenitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Biliary fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
65
term
Anaphylactic shock

time Frame

From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.

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Preserved source evidence · Not medical advice