NCT01248949 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors · Source last updated 2017-03-29

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: From start of study drug administration up to 90 days after the last dose of MEDI3617
Other-event reporting threshold: 3%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
MEDI3617 SINGLE AGENT TOTAL Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.	18 / 42	40 / 42	Not reported / Not reported
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.	4 / 16	16 / 16	Not reported / Not reported
MEDI3617 + BEVACIZUMAB Q2W TOTAL Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.	18 / 38	34 / 38	Not reported / Not reported
MEDI3617 + PACLITAXEL TOTAL Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.	7 / 13	13 / 13	Not reported / Not reported
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.	4 / 7	7 / 7	Not reported / Not reported

Group identifiers: EG000: MEDI3617 SINGLE AGENT TOTAL · EG001: MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL · EG002: MEDI3617 + BEVACIZUMAB Q2W TOTAL · EG003: MEDI3617 + PACLITAXEL TOTAL · EG004: MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL

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 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
3
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Faecal incontinence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
2
num At Risk
42
num Events
2
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
1
num At Risk
38
num Events
2
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Pancreatitis acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
3
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
1
num At Risk
38
num Events
2
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Small intestinal obstruction

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 18.1
stats
group Id
EG000
num Affected
4
num At Risk
42
num Events
5
group Id
EG001
num Affected
1
num At Risk
16
num Events
1
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
2
num At Risk
13
num Events
2
group Id
EG004
num Affected
2
num At Risk
7
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
3
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
2
num At Risk
13
num Events
2
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
3
group Id
EG001
num Affected
1
num At Risk
16
num Events
1
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
4
group Id
EG001
num Affected
1
num At Risk
16
num Events
1
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
7
num At Risk
42
num Events
7
group Id
EG001
num Affected
2
num At Risk
16
num Events
2
group Id
EG002
num Affected
3
num At Risk
38
num Events
3
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
3
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
16
num At Risk
42
num Events
19
group Id
EG001
num Affected
9
num At Risk
16
num Events
12
group Id
EG002
num Affected
4
num At Risk
38
num Events
4
group Id
EG003
num Affected
4
num At Risk
13
num Events
6
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
8
num At Risk
42
num Events
11
group Id
EG001
num Affected
5
num At Risk
16
num Events
7
group Id
EG002
num Affected
3
num At Risk
38
num Events
4
group Id
EG003
num Affected
4
num At Risk
13
num Events
4
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
7
num At Risk
42
num Events
7
group Id
EG001
num Affected
2
num At Risk
16
num Events
3
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
4
num At Risk
42
num Events
4
group Id
EG001
num Affected
1
num At Risk
16
num Events
1
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
2
num At Risk
13
num Events
2
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
1
num At Risk
16
num Events
1
group Id
EG002
num Affected
2
num At Risk
38
num Events
2
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
2
num At Risk
16
num Events
2
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Gingival pain

Complete source fields

event Groups

description
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
id
EG000
other Num Affected
40
other Num At Risk
42
serious Num Affected
18
serious Num At Risk
42
title
MEDI3617 SINGLE AGENT TOTAL
description
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
id
EG001
other Num Affected
16
other Num At Risk
16
serious Num Affected
4
serious Num At Risk
16
title
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
description
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
id
EG002
other Num Affected
34
other Num At Risk
38
serious Num Affected
18
serious Num At Risk
38
title
MEDI3617 + BEVACIZUMAB Q2W TOTAL
description
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
id
EG003
other Num Affected
13
other Num At Risk
13
serious Num Affected
7
serious Num At Risk
13
title
MEDI3617 + PACLITAXEL TOTAL
description
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
id
EG004
other Num Affected
7
other Num At Risk
7
serious Num Affected
4
serious Num At Risk
7
title
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
4
num At Risk
42
num Events
5
group Id
EG001
num Affected
1
num At Risk
16
num Events
1
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
2
num At Risk
13
num Events
2
group Id
EG004
num Affected
2
num At Risk
7
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
3
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
2
num At Risk
13
num Events
2
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
3
group Id
EG001
num Affected
1
num At Risk
16
num Events
1
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
4
group Id
EG001
num Affected
1
num At Risk
16
num Events
1
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
7
num At Risk
42
num Events
7
group Id
EG001
num Affected
2
num At Risk
16
num Events
2
group Id
EG002
num Affected
3
num At Risk
38
num Events
3
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
3
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
16
num At Risk
42
num Events
19
group Id
EG001
num Affected
9
num At Risk
16
num Events
12
group Id
EG002
num Affected
4
num At Risk
38
num Events
4
group Id
EG003
num Affected
4
num At Risk
13
num Events
6
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
8
num At Risk
42
num Events
11
group Id
EG001
num Affected
5
num At Risk
16
num Events
7
group Id
EG002
num Affected
3
num At Risk
38
num Events
4
group Id
EG003
num Affected
4
num At Risk
13
num Events
4
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
7
num At Risk
42
num Events
7
group Id
EG001
num Affected
2
num At Risk
16
num Events
3
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
4
num At Risk
42
num Events
4
group Id
EG001
num Affected
1
num At Risk
16
num Events
1
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
2
num At Risk
13
num Events
2
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
1
num At Risk
16
num Events
1
group Id
EG002
num Affected
2
num At Risk
38
num Events
2
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
2
num At Risk
16
num Events
2
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Gingival pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
3
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
0
num At Risk
38
num Events
0
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Faecal incontinence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
2
num At Risk
42
num Events
2
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
1
num At Risk
38
num Events
2
group Id
EG003
num Affected
1
num At Risk
13
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
1
num At Risk
38
num Events
1
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Pancreatitis acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 18.1
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
3
group Id
EG001
num Affected
0
num At Risk
16
num Events
0
group Id
EG002
num Affected
1
num At Risk
38
num Events
2
group Id
EG003
num Affected
0
num At Risk
13
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
term
Small intestinal obstruction

time Frame

From start of study drug administration up to 90 days after the last dose of MEDI3617

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

Preserved source evidence · Not medical advice