NCT02514239 · ADVERSE EVENTS

Adverse events

Phase I Dose Escalation of i.v. BI 836909 Monotherapy in Last Line Multiple Myeloma Patients · Source last updated 2022-02-24

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: Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Other-event reporting threshold: 5%

Treated set (TS): all patients who were administered trial medication.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Intravenous Infusion of BI 836909 (0.2 μg/d) Intravenous infusion of BI 836909 (0.2 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.	1 / 1	1 / 1	0 / 1
Intravenous Infusion of BI 836909 (0.4 μg/d) Intravenous infusion of BI 836909 (0.4 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.	0 / 1	1 / 1	0 / 1
Intravenous Infusion of BI 836909 (0.8 μg/d) Intravenous infusion of BI 836909 (0.8 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.	1 / 2	1 / 2	0 / 2
Intravenous Infusion of BI 836909 (1.6 μg/d) Intravenous infusion of BI 836909 (1.6 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.	0 / 1	1 / 1	0 / 1
Intravenous Infusion of BI 836909 (3.2 μg/d) Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.	1 / 3	3 / 3	0 / 3
Intravenous Infusion of BI 836909 (6.5 μg/d) Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.	3 / 3	3 / 3	0 / 3
Intravenous Infusion of BI 836909 (13 μg/d) Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.	1 / 3	3 / 3	0 / 3
Intravenous Infusion of BI 836909 (25 μg/d) Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.	1 / 3	3 / 3	0 / 3
Intravenous Infusion of BI 836909 (50 μg/d) Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.	3 / 5	5 / 5	1 / 5
Intravenous Infusion of BI 836909 (100 μg/d) Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.	2 / 4	4 / 4	0 / 4
Intravenous Infusion of BI 836909 (200 μg/d) Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.	3 / 3	3 / 3	0 / 3
Intravenous Infusion of BI 836909 (400 μg/d) Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.	8 / 10	10 / 10	1 / 10
Intravenous Infusion of BI 836909 (800 μg/d) Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.	3 / 3	2 / 3	0 / 3
Intravenous Infusion of BI 836909 (Total Dose Escalation) BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.	27 / 42	40 / 42	2 / 42

Group identifiers: EG000: Intravenous Infusion of BI 836909 (0.2 μg/d) · EG001: Intravenous Infusion of BI 836909 (0.4 μg/d) · EG002: Intravenous Infusion of BI 836909 (0.8 μg/d) · EG003: Intravenous Infusion of BI 836909 (1.6 μg/d) · EG004: Intravenous Infusion of BI 836909 (3.2 μg/d) · EG005: Intravenous Infusion of BI 836909 (6.5 μg/d) · EG006: Intravenous Infusion of BI 836909 (13 μg/d) · EG007: Intravenous Infusion of BI 836909 (25 μg/d) · EG008: Intravenous Infusion of BI 836909 (50 μg/d) · EG009: Intravenous Infusion of BI 836909 (100 μg/d) · EG010: Intravenous Infusion of BI 836909 (200 μg/d) · EG011: Intravenous Infusion of BI 836909 (400 μg/d) · EG012: Intravenous Infusion of BI 836909 (800 μg/d) · EG013: Intravenous Infusion of BI 836909 (Total Dose Escalation)

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
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
10
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
1
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Generalised oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Bile duct obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
10
term
Hepatic failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
3
num At Risk
10
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Aspergillus infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Catheter site infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
10
term
Influenza

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 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
2
num At Risk
5
group Id
EG009
num Affected
2
num At Risk
4
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
5
num At Risk
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
10
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
10
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
10
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
1
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Eustachian tube dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Vertigo positional
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Hyperthyroidism

Complete source fields

description

Treated set (TS): all patients who were administered trial medication.

event Groups

deaths Num Affected
0
deaths Num At Risk
1
description
Intravenous infusion of BI 836909 (0.2 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Intravenous Infusion of BI 836909 (0.2 μg/d)
deaths Num Affected
0
deaths Num At Risk
1
description
Intravenous infusion of BI 836909 (0.4 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
id
EG001
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Intravenous Infusion of BI 836909 (0.4 μg/d)
deaths Num Affected
0
deaths Num At Risk
2
description
Intravenous infusion of BI 836909 (0.8 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
id
EG002
other Num Affected
1
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
Intravenous Infusion of BI 836909 (0.8 μg/d)
deaths Num Affected
0
deaths Num At Risk
1
description
Intravenous infusion of BI 836909 (1.6 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
id
EG003
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Intravenous Infusion of BI 836909 (1.6 μg/d)
deaths Num Affected
0
deaths Num At Risk
3
description
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Intravenous Infusion of BI 836909 (3.2 μg/d)
deaths Num Affected
0
deaths Num At Risk
3
description
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
id
EG005
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Intravenous Infusion of BI 836909 (6.5 μg/d)
deaths Num Affected
0
deaths Num At Risk
3
description
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
id
EG006
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Intravenous Infusion of BI 836909 (13 μg/d)
deaths Num Affected
0
deaths Num At Risk
3
description
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
id
EG007
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Intravenous Infusion of BI 836909 (25 μg/d)
deaths Num Affected
1
deaths Num At Risk
5
description
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
id
EG008
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
Intravenous Infusion of BI 836909 (50 μg/d)
deaths Num Affected
0
deaths Num At Risk
4
description
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
id
EG009
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Intravenous Infusion of BI 836909 (100 μg/d)
deaths Num Affected
0
deaths Num At Risk
3
description
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
id
EG010
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Intravenous Infusion of BI 836909 (200 μg/d)
deaths Num Affected
1
deaths Num At Risk
10
description
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
id
EG011
other Num Affected
10
other Num At Risk
10
serious Num Affected
8
serious Num At Risk
10
title
Intravenous Infusion of BI 836909 (400 μg/d)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
2
num At Risk
5
group Id
EG009
num Affected
2
num At Risk
4
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
5
num At Risk
10
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
10
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
10
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
10
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
1
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Eustachian tube dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Vertigo positional
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Hyperthyroidism

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
10
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
1
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Generalised oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Bile duct obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
10
term
Hepatic failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
3
num At Risk
10
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Aspergillus infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Catheter site infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
10
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
2
group Id
EG003
num Affected
0
num At Risk
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
4
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
10
term
Influenza

time Frame

Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.

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

Preserved source evidence · Not medical advice