NCT00648739 · ADVERSE EVENTS

Adverse events

Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM · Source last updated 2019-03-05

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 Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Samalizumab 50 mg/m^2 Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	1 / 4	4 / 4	0 / 4
Samalizumab 100 mg/m^2 Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	2 / 5	5 / 5	1 / 5
Samalizumab 200 mg/m^2 Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	0 / 3	3 / 3	0 / 3
Samalizumab 300 mg/m^2 Participants assigned to this dose cohort received a single IV 300 mg/m\^2 dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	1 / 3	3 / 3	0 / 3
Samalizumab 400 mg/m^2 Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	1 / 3	3 / 3	0 / 3
Samalizumab 500 mg/m^2 Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	1 / 7	6 / 7	0 / 7
Samalizumab 600 mg/m^2 Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	0 / 1	1 / 1	0 / 1

Group identifiers: EG000: Samalizumab 50 mg/m^2 · EG001: Samalizumab 100 mg/m^2 · EG002: Samalizumab 200 mg/m^2 · EG003: Samalizumab 300 mg/m^2 · EG004: Samalizumab 400 mg/m^2 · EG005: Samalizumab 500 mg/m^2 · EG006: Samalizumab 600 mg/m^2

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
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Visual acuity reduced
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Respiratory syncytial virus infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Muscular weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Hemorrhage intracranial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Renal failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Chronic obstructive pulmonary disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Cholecystectomy

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 (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Conjunctival haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Eye irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Eye pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Night blindness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Photophobia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Photopsia

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
4
description
Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Samalizumab 50 mg/m^2
deaths Num Affected
1
deaths Num At Risk
5
description
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
id
EG001
other Num Affected
5
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
Samalizumab 100 mg/m^2
deaths Num Affected
0
deaths Num At Risk
3
description
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Samalizumab 200 mg/m^2
deaths Num Affected
0
deaths Num At Risk
3
description
Participants assigned to this dose cohort received a single IV 300 mg/m\^2 dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Samalizumab 300 mg/m^2
deaths Num Affected
0
deaths Num At Risk
3
description
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Samalizumab 400 mg/m^2
deaths Num Affected
0
deaths Num At Risk
7
description
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
id
EG005
other Num Affected
6
other Num At Risk
7
serious Num Affected
1
serious Num At Risk
7
title
Samalizumab 500 mg/m^2
deaths Num Affected
0
deaths Num At Risk
1
description
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
id
EG006
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Samalizumab 600 mg/m^2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Conjunctival haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Eye irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Eye pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Night blindness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Photophobia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Photopsia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Visual acuity reduced
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Respiratory syncytial virus infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Muscular weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Hemorrhage intracranial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Renal failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Chronic obstructive pulmonary disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
source Vocabulary
MedDRA (11.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
1
term
Cholecystectomy

time Frame

From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice