NCT01761240 · ADVERSE EVENTS

Adverse events

Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC · Source last updated 2024-03-29

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: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
MORAb-066 0.1 mg/kg Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	0 / 3	3 / 3	0 / 3
MORAb-066 0.3 mg/kg Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	1 / 4	4 / 4	1 / 4
MORAb-066 1 mg/kg Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	3 / 5	5 / 5	1 / 5
MORAb-066 2 mg/kg Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	4 / 7	7 / 7	2 / 7
MORAb-066 3 mg/kg Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.	3 / 8	8 / 8	1 / 8

Group identifiers: EG000: MORAb-066 0.1 mg/kg · EG001: MORAb-066 0.3 mg/kg · EG002: MORAb-066 1 mg/kg · EG003: MORAb-066 2 mg/kg · EG004: MORAb-066 3 mg/kg

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
Hepatobiliary disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Cholangitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Gastric haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Mental status changes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Haematuria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Haemoptysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
2
num At Risk
8
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Coagulopathy

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
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
4
group Id
EG002
num Affected
4
num At Risk
5
group Id
EG003
num Affected
3
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
4
group Id
EG002
num Affected
4
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Gingival bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Haematochezia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Colitis microscopic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Duodenitis

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
MORAb-066 0.1 mg/kg
deaths Num Affected
1
deaths Num At Risk
4
description
Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
MORAb-066 0.3 mg/kg
deaths Num Affected
1
deaths Num At Risk
5
description
Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
id
EG002
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
MORAb-066 1 mg/kg
deaths Num Affected
2
deaths Num At Risk
7
description
Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
id
EG003
other Num Affected
7
other Num At Risk
7
serious Num Affected
4
serious Num At Risk
7
title
MORAb-066 2 mg/kg
deaths Num Affected
1
deaths Num At Risk
8
description
Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
id
EG004
other Num Affected
8
other Num At Risk
8
serious Num Affected
3
serious Num At Risk
8
title
MORAb-066 3 mg/kg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
4
group Id
EG002
num Affected
4
num At Risk
5
group Id
EG003
num Affected
3
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
4
group Id
EG002
num Affected
4
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Gingival bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Haematochezia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Colitis microscopic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Duodenitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Cholangitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Gastric haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Mental status changes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Haematuria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
term
Haemoptysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
2
num At Risk
8
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
term
Coagulopathy

time Frame

First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months)

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

Preserved source evidence · Not medical advice