NCT00089076 · ADVERSE EVENTS

Adverse events

MDX-010 in Treating Patients With Recurrent or Refractory Lymphoma · Source last updated 2014-05-30

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
MDX-010 Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.	8 / 18	16 / 18	Not reported / Not reported

Group identifiers: EG000: MDX-010

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
18
num Events
3
term
Diarrhea-No Colostom
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Blood gonadotrophin abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Weight loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Myalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Facial nerve disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Pneumonitis

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 6
stats
group Id
EG000
num Affected
4
num At Risk
18
num Events
7
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
3
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
9
num At Risk
18
num Events
11
term
Diarrhea-No Colostom
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
2
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
2
term
Lip pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
18
num Events
4
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Oral cavity Mucositis/stomatitis (functional/symptomatic)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
6
num At Risk
18
num Events
9
term
Pain-Abdominal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Pain-Stomach

Complete source fields

event Groups

description
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
16
other Num At Risk
18
serious Num Affected
8
serious Num At Risk
18
title
MDX-010

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
4
num At Risk
18
num Events
7
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
3
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
9
num At Risk
18
num Events
11
term
Diarrhea-No Colostom
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
2
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
2
term
Lip pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
18
num Events
4
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Oral cavity Mucositis/stomatitis (functional/symptomatic)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
6
num At Risk
18
num Events
9
term
Pain-Abdominal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Pain-Stomach

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
18
num Events
3
term
Diarrhea-No Colostom
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Blood gonadotrophin abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Weight loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Myalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Facial nerve disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Pneumonitis

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