NCT02675452 · ADVERSE EVENTS

Adverse events

AMG 176 First in Human Trial in Participants With Relapsed or Refractory Multiple Myeloma and Participants With Relapsed or Refractory Acute Myeloid Leukemia · Source last updated 2025-07-09

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: For mortality, from enrolment to end of study; median time on study was 2.3 months. For AEs, from first dose of AMG 176 to 30 days after the last dose of AMG 176; median treatment duration was 1.2 months.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1A Cohort 1 (MM): AMG 176 Dose A BIW Participants with MM received AMG 176 Dose A BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.	0 / 3	3 / 3	0 / 3
Part 1A Cohort 2 (MM): AMG 176 Dose B BIW Participants with MM received AMG 176 Dose B IV BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.	1 / 3	2 / 3	0 / 3
Part 1A Cohort 3 (MM): AMG 176 Dose C BIW Participants with MM received AMG 176 Dose C BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.	1 / 4	4 / 4	1 / 4
Part 1A Cohort 4 (MM): AMG 176 Dose D BIW Participants with MM received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.	0 / 3	3 / 3	0 / 3
Part 1A Cohort 5 (MM): AMG 176 Dose E BIW Participants with MM received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.	1 / 3	3 / 3	0 / 3
Part 1A Cohort 6 (MM): AMG 176 Dose G BIW Participants with MM received AMG 176 Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.	2 / 2	1 / 2	1 / 2
Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.	3 / 4	4 / 4	0 / 4
Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.	0 / 4	4 / 4	0 / 4
Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.	2 / 5	5 / 5	1 / 5
Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.	3 / 5	5 / 5	0 / 5
Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.	0 / 3	3 / 3	0 / 3
Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.	2 / 3	3 / 3	0 / 3
Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H QW. AMG 176 was administered as an IV infusion in a 4-week cycle.	1 / 3	3 / 3	1 / 3
Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I QW. AMG 176 was administered as an IV infusion in a 4-week cycle.	1 / 3	3 / 3	0 / 3
Part 3A Cohort 1 (AML): AMG 176 Dose D BIW Participants with AML received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.	3 / 5	4 / 5	0 / 5
Part 3A Cohort 2 (AML): AMG 176 Dose E BIW Participants with AML received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.	4 / 5	3 / 5	2 / 5
Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose F BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.	3 / 5	5 / 5	0 / 5
Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW Japanese participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.	2 / 2	2 / 2	0 / 2
Part 3B Cohort 1 (AML): AMG 176 Dose E QW Participants with AML received AMG 176 Dose E QW. AMG 176 was administered as an IV infusion in a 4-week cycle.	2 / 4	4 / 4	4 / 4
Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.	2 / 3	3 / 3	3 / 3
Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.	4 / 4	4 / 4	3 / 4
Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW Japanese participants with AML received AMG 176 Dose E QW. AMG 176 was administered as an IV infusion in a 4-week cycle.	1 / 4	4 / 4	3 / 4
Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole Participants with AML received AMG 176 Dose D QW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 200 mg itraconazole QD for 7 days in week 1.	8 / 10	10 / 10	7 / 10
Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine Participants with AML received AMG 176 Dose D QW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.	4 / 5	5 / 5	5 / 5
Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine Participants with AML received AMG 176 Dose E QW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for the first 7 days of the 4-week cycle.	4 / 4	4 / 4	3 / 4
Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.	4 / 4	4 / 4	4 / 4
Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for the first 7 days of the 4-week cycle.	10 / 13	13 / 13	7 / 13
Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine Participants with AML received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.	8 / 10	10 / 10	6 / 10
Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.	10 / 13	13 / 13	9 / 13

Group identifiers: EG000: Part 1A Cohort 1 (MM): AMG 176 Dose A BIW · EG001: Part 1A Cohort 2 (MM): AMG 176 Dose B BIW · EG002: Part 1A Cohort 3 (MM): AMG 176 Dose C BIW · EG003: Part 1A Cohort 4 (MM): AMG 176 Dose D BIW · EG004: Part 1A Cohort 5 (MM): AMG 176 Dose E BIW · EG005: Part 1A Cohort 6 (MM): AMG 176 Dose G BIW · EG006: Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW · EG007: Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW · EG008: Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW · EG009: Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW · EG010: Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW · EG011: Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW · EG012: Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW · EG013: Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW · EG014: Part 3A Cohort 1 (AML): AMG 176 Dose D BIW · EG015: Part 3A Cohort 2 (AML): AMG 176 Dose E BIW · EG016: Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW · EG017: Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW · EG018: Part 3B Cohort 1 (AML): AMG 176 Dose E QW · EG019: Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW · EG020: Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW · EG021: Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW · EG022: Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole · EG023: Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine · EG024: Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine · EG025: Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine · EG026: Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine · EG027: Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine · EG028: Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine

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 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Atrioventricular block second degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
1
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Gastric haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Gastric mucosal lesion

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 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
3
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
4
group Id
EG008
num Affected
3
num At Risk
5
group Id
EG009
num Affected
4
num At Risk
5
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Coagulation factor deficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
1
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
4
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
3
num At Risk
5
group Id
EG010
num Affected
2
num At Risk
3
group Id
EG011
num Affected
2
num At Risk
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
1
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Splenomegaly
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Stress polycythaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
1
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Thrombocytopenia

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
Participants with MM received AMG 176 Dose A BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Part 1A Cohort 1 (MM): AMG 176 Dose A BIW
deaths Num Affected
0
deaths Num At Risk
3
description
Participants with MM received AMG 176 Dose B IV BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
id
EG001
other Num Affected
2
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part 1A Cohort 2 (MM): AMG 176 Dose B BIW
deaths Num Affected
1
deaths Num At Risk
4
description
Participants with MM received AMG 176 Dose C BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
id
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Part 1A Cohort 3 (MM): AMG 176 Dose C BIW
deaths Num Affected
0
deaths Num At Risk
3
description
Participants with MM received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Part 1A Cohort 4 (MM): AMG 176 Dose D BIW
deaths Num Affected
0
deaths Num At Risk
3
description
Participants with MM received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part 1A Cohort 5 (MM): AMG 176 Dose E BIW
deaths Num Affected
1
deaths Num At Risk
2
description
Participants with MM received AMG 176 Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
id
EG005
other Num Affected
1
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Part 1A Cohort 6 (MM): AMG 176 Dose G BIW
deaths Num Affected
0
deaths Num At Risk
4
description
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
id
EG006
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW
deaths Num Affected
0
deaths Num At Risk
4
description
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
id
EG007
other Num Affected
4
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW
deaths Num Affected
1
deaths Num At Risk
5
description
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
id
EG008
other Num Affected
5
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW
deaths Num Affected
0
deaths Num At Risk
5
description
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
id
EG009
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW
deaths Num Affected
0
deaths Num At Risk
3
description
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
id
EG010
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW
deaths Num Affected
0
deaths Num At Risk
3
description
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
id
EG011
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
3
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
2
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
4
group Id
EG008
num Affected
3
num At Risk
5
group Id
EG009
num Affected
4
num At Risk
5
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Coagulation factor deficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
1
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
4
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
3
num At Risk
5
group Id
EG010
num Affected
2
num At Risk
3
group Id
EG011
num Affected
2
num At Risk
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
1
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Splenomegaly
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Stress polycythaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
1
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Thrombocytopenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Atrioventricular block second degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
1
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Gastric haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
2
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
5
group Id
EG009
num Affected
0
num At Risk
5
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
3
term
Gastric mucosal lesion

time Frame

For mortality, from enrolment to end of study; median time on study was 2.3 months. For AEs, from first dose of AMG 176 to 30 days after the last dose of AMG 176; median treatment duration was 1.2 months.

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Preserved source evidence · Not medical advice