NCT01421186 · ADVERSE EVENTS

Adverse events

A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma · Source last updated 2021-11-16

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: during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
Other-event reporting threshold: 5%

regular investigator assessment and laboratory testing

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part A: MOR03087 Biweekly Dose Escalation Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg	13 / 31	31 / 31	2 / 31
Part B: MOR03087 Weekly Dose Escalation Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment. MOR03087: MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E..	4 / 4	4 / 4	0 / 4
Part C: MOR03087 Plus Dexamethasone Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)	7 / 18	18 / 18	0 / 18
Part D: MOR03087 Plus Pomalidomide + Dexamethasone Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.	20 / 21	21 / 21	1 / 21
Part E: MOR03087 Plus Lenalidomide + Dexamethasone Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.	14 / 17	17 / 17	4 / 17

Group identifiers: EG000: Part A: MOR03087 Biweekly Dose Escalation · EG001: Part B: MOR03087 Weekly Dose Escalation · EG002: Part C: MOR03087 Plus Dexamethasone · EG003: Part D: MOR03087 Plus Pomalidomide + Dexamethasone · EG004: Part E: MOR03087 Plus Lenalidomide + Dexamethasone

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
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
18
num Events
1
group Id
EG003
num Affected
6
num At Risk
21
num Events
9
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
3
num At Risk
21
num Events
3
group Id
EG004
num Affected
0
num At Risk
17
term
Respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
2
num At Risk
18
num Events
2
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
17
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Pneumonia influenzal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Pulmonary Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Skin Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
4
num At Risk
31
num Events
4
group Id
EG001
num Affected
4
num At Risk
4
num Events
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
0
num At Risk
17
term
Infusion-related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
4
num At Risk
31
num Events
4
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Plasma Cell Myeloma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Breast Cancer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
31
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
1
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
2
group Id
EG004
num Affected
0
num At Risk
17
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
1
num At Risk
4
num Events
3
group Id
EG002
num Affected
0
num At Risk
18
num Events
0
group Id
EG003
num Affected
1
num At Risk
21
num Events
2
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Atrial Fibrillation

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
8
num At Risk
31
num Events
13
group Id
EG001
num Affected
4
num At Risk
4
num Events
7
group Id
EG002
num Affected
8
num At Risk
18
num Events
28
group Id
EG003
num Affected
17
num At Risk
21
num Events
91
group Id
EG004
num Affected
15
num At Risk
17
num Events
55
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
6
num At Risk
31
num Events
8
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
9
num At Risk
18
num Events
12
group Id
EG003
num Affected
4
num At Risk
21
num Events
12
group Id
EG004
num Affected
6
num At Risk
17
num Events
10
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
4
num At Risk
31
num Events
4
group Id
EG001
num Affected
3
num At Risk
4
num Events
12
group Id
EG002
num Affected
8
num At Risk
18
num Events
26
group Id
EG003
num Affected
19
num At Risk
21
num Events
113
group Id
EG004
num Affected
12
num At Risk
17
num Events
49
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
5
num At Risk
31
num Events
9
group Id
EG001
num Affected
2
num At Risk
4
num Events
4
group Id
EG002
num Affected
8
num At Risk
18
num Events
25
group Id
EG003
num Affected
14
num At Risk
21
num Events
43
group Id
EG004
num Affected
13
num At Risk
17
num Events
33
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
13
num At Risk
31
num Events
20
group Id
EG001
num Affected
1
num At Risk
4
num Events
3
group Id
EG002
num Affected
7
num At Risk
18
num Events
10
group Id
EG003
num Affected
11
num At Risk
21
num Events
34
group Id
EG004
num Affected
6
num At Risk
17
num Events
16
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
31
num Events
3
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
6
num At Risk
18
num Events
9
group Id
EG003
num Affected
14
num At Risk
21
num Events
51
group Id
EG004
num Affected
11
num At Risk
17
num Events
24
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
2
group Id
EG002
num Affected
3
num At Risk
18
num Events
8
group Id
EG003
num Affected
3
num At Risk
21
num Events
10
group Id
EG004
num Affected
3
num At Risk
17
num Events
3
term
C-reactive proteine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
18
num Events
1
group Id
EG003
num Affected
4
num At Risk
21
num Events
4
group Id
EG004
num Affected
4
num At Risk
17
num Events
6
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
31
num Events
3
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
18
num Events
1
group Id
EG003
num Affected
2
num At Risk
21
num Events
2
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Blood lactate dehydrogenase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
18
num Events
0
group Id
EG003
num Affected
2
num At Risk
21
num Events
3
group Id
EG004
num Affected
4
num At Risk
17
num Events
6
term
Gamma-glutamyltransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
3
num At Risk
18
num Events
14
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
3
num At Risk
17
num Events
3
term
Lipase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
18
num Events
5
group Id
EG003
num Affected
2
num At Risk
21
num Events
2
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Amylase increased

Complete source fields

description

regular investigator assessment and laboratory testing

event Groups

deaths Num Affected
2
deaths Num At Risk
31
description
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
id
EG000
other Num Affected
31
other Num At Risk
31
serious Num Affected
13
serious Num At Risk
31
title
Part A: MOR03087 Biweekly Dose Escalation
deaths Num Affected
0
deaths Num At Risk
4
description
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment. MOR03087: MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E..
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
4
serious Num At Risk
4
title
Part B: MOR03087 Weekly Dose Escalation
deaths Num Affected
0
deaths Num At Risk
18
description
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
id
EG002
other Num Affected
18
other Num At Risk
18
serious Num Affected
7
serious Num At Risk
18
title
Part C: MOR03087 Plus Dexamethasone
deaths Num Affected
1
deaths Num At Risk
21
description
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
id
EG003
other Num Affected
21
other Num At Risk
21
serious Num Affected
20
serious Num At Risk
21
title
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
deaths Num Affected
4
deaths Num At Risk
17
description
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
id
EG004
other Num Affected
17
other Num At Risk
17
serious Num Affected
14
serious Num At Risk
17
title
Part E: MOR03087 Plus Lenalidomide + Dexamethasone

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
8
num At Risk
31
num Events
13
group Id
EG001
num Affected
4
num At Risk
4
num Events
7
group Id
EG002
num Affected
8
num At Risk
18
num Events
28
group Id
EG003
num Affected
17
num At Risk
21
num Events
91
group Id
EG004
num Affected
15
num At Risk
17
num Events
55
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
6
num At Risk
31
num Events
8
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
9
num At Risk
18
num Events
12
group Id
EG003
num Affected
4
num At Risk
21
num Events
12
group Id
EG004
num Affected
6
num At Risk
17
num Events
10
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
4
num At Risk
31
num Events
4
group Id
EG001
num Affected
3
num At Risk
4
num Events
12
group Id
EG002
num Affected
8
num At Risk
18
num Events
26
group Id
EG003
num Affected
19
num At Risk
21
num Events
113
group Id
EG004
num Affected
12
num At Risk
17
num Events
49
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
5
num At Risk
31
num Events
9
group Id
EG001
num Affected
2
num At Risk
4
num Events
4
group Id
EG002
num Affected
8
num At Risk
18
num Events
25
group Id
EG003
num Affected
14
num At Risk
21
num Events
43
group Id
EG004
num Affected
13
num At Risk
17
num Events
33
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
13
num At Risk
31
num Events
20
group Id
EG001
num Affected
1
num At Risk
4
num Events
3
group Id
EG002
num Affected
7
num At Risk
18
num Events
10
group Id
EG003
num Affected
11
num At Risk
21
num Events
34
group Id
EG004
num Affected
6
num At Risk
17
num Events
16
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
31
num Events
3
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
group Id
EG002
num Affected
6
num At Risk
18
num Events
9
group Id
EG003
num Affected
14
num At Risk
21
num Events
51
group Id
EG004
num Affected
11
num At Risk
17
num Events
24
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
2
group Id
EG002
num Affected
3
num At Risk
18
num Events
8
group Id
EG003
num Affected
3
num At Risk
21
num Events
10
group Id
EG004
num Affected
3
num At Risk
17
num Events
3
term
C-reactive proteine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
18
num Events
1
group Id
EG003
num Affected
4
num At Risk
21
num Events
4
group Id
EG004
num Affected
4
num At Risk
17
num Events
6
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
31
num Events
3
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
18
num Events
1
group Id
EG003
num Affected
2
num At Risk
21
num Events
2
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Blood lactate dehydrogenase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
18
num Events
0
group Id
EG003
num Affected
2
num At Risk
21
num Events
3
group Id
EG004
num Affected
4
num At Risk
17
num Events
6
term
Gamma-glutamyltransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
3
num At Risk
18
num Events
14
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
3
num At Risk
17
num Events
3
term
Lipase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
2
num At Risk
18
num Events
5
group Id
EG003
num Affected
2
num At Risk
21
num Events
2
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Amylase increased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
31
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
18
num Events
1
group Id
EG003
num Affected
6
num At Risk
21
num Events
9
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
3
num At Risk
21
num Events
3
group Id
EG004
num Affected
0
num At Risk
17
term
Respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
2
num At Risk
18
num Events
2
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
17
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Pneumonia influenzal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Pulmonary Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Skin Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
4
num At Risk
31
num Events
4
group Id
EG001
num Affected
4
num At Risk
4
num Events
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
0
num At Risk
17
term
Infusion-related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
4
num At Risk
31
num Events
4
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
0
num At Risk
21
num Events
0
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Plasma Cell Myeloma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
1
num At Risk
17
num Events
1
term
Breast Cancer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
31
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
1
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
1
num At Risk
4
num Events
2
group Id
EG002
num Affected
0
num At Risk
18
group Id
EG003
num Affected
1
num At Risk
21
num Events
2
group Id
EG004
num Affected
0
num At Risk
17
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
31
group Id
EG001
num Affected
1
num At Risk
4
num Events
3
group Id
EG002
num Affected
0
num At Risk
18
num Events
0
group Id
EG003
num Affected
1
num At Risk
21
num Events
2
group Id
EG004
num Affected
0
num At Risk
17
num Events
0
term
Atrial Fibrillation

time Frame

during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.

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

Preserved source evidence · Not medical advice