NCT02064387 · ADVERSE EVENTS

Adverse events

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 · Source last updated 2020-08-11

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: SAEs & common (>=5%) non-SAEs were collected from start of study treatment until 23.5 months for Part 1, 35 months for Part 2 (MM) and 7.2 months for Part 2 (NHL)
Other-event reporting threshold: 5%

SAEs and common (\>=5%) non-SAEs were reported by treatment for the Part 1 Population which comprised of all Part 1 participants (exclusively MM) who received at least one dose of GSK2857916; Part 2 MM and NHL Population which comprised of all Part 2 MM and NHL participants who received at least one dose of GSK2857916.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1: GSK2857916 0.03 mg/kg Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).	0 / 1	1 / 1	0 / 1
Part 1: GSK2857916 0.06 mg/kg Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).	0 / 1	1 / 1	0 / 1
Part 1: GSK2857916 0.12 mg/kg Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).	1 / 4	4 / 4	0 / 4
Part 1: GSK2857916 0.24 mg/kg Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).	1 / 4	4 / 4	0 / 4
Part 1: GSK2857916 0.48 mg/kg Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).	1 / 4	3 / 4	0 / 4
Part 1: GSK2857916 0.96 mg/kg Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).	0 / 3	3 / 3	0 / 3
Part 1: GSK2857916 1.92 mg/kg Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).	2 / 4	4 / 4	0 / 4
Part 1: GSK2857916 2.50 mg/kg Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).	4 / 8	8 / 8	1 / 8
Part 1: GSK2857916 3.40 mg/kg Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).	1 / 3	3 / 3	0 / 3
Part 1: GSK2857916 4.60 mg/kg Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).	3 / 6	6 / 6	1 / 6
Part 2: GSK2857916 3.40 mg/kg (MM) Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).	17 / 35	35 / 35	5 / 35
Part 2: GSK2857916 3.40 mg/kg (NHL) Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days).	3 / 6	6 / 6	3 / 6

Group identifiers: EG000: Part 1: GSK2857916 0.03 mg/kg · EG001: Part 1: GSK2857916 0.06 mg/kg · EG002: Part 1: GSK2857916 0.12 mg/kg · EG003: Part 1: GSK2857916 0.24 mg/kg · EG004: Part 1: GSK2857916 0.48 mg/kg · EG005: Part 1: GSK2857916 0.96 mg/kg · EG006: Part 1: GSK2857916 1.92 mg/kg · EG007: Part 1: GSK2857916 2.50 mg/kg · EG008: Part 1: GSK2857916 3.40 mg/kg · EG009: Part 1: GSK2857916 4.60 mg/kg · EG010: Part 2: GSK2857916 3.40 mg/kg (MM) · EG011: Part 2: GSK2857916 3.40 mg/kg (NHL)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Adenovirus infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Babesiosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Basal cell carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Cholecystitis infective
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Deep vein thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Fall

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
2
num At Risk
35
num Events
2
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
2
num At Risk
35
num Events
2
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
1
num At Risk
3
num Events
1
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Acne
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
2
group Id
EG010
num Affected
7
num At Risk
35
num Events
8
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Albuminuria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
4
num Events
1
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Alpha haemolytic streptococcal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
2
num At Risk
3
num Events
4
group Id
EG006
num Affected
1
num At Risk
4
num Events
1
group Id
EG007
num Affected
3
num At Risk
8
num Events
3
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
3
num At Risk
6
num Events
4
group Id
EG010
num Affected
10
num At Risk
35
num Events
12
group Id
EG011
num Affected
1
num At Risk
6
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Angina bullosa haemorrhagica
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
2
num At Risk
4
num Events
2
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
4
num Events
4
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
4
num At Risk
35
num Events
5
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
4
num Events
1
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
2
num At Risk
3
num Events
3
group Id
EG009
num Affected
4
num At Risk
6
num Events
5
group Id
EG010
num Affected
13
num At Risk
35
num Events
17
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Asthenia

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
1
description
Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Part 1: GSK2857916 0.03 mg/kg
deaths Num Affected
0
deaths Num At Risk
1
description
Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
EG001
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Part 1: GSK2857916 0.06 mg/kg
deaths Num Affected
0
deaths Num At Risk
4
description
Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Part 1: GSK2857916 0.12 mg/kg
deaths Num Affected
0
deaths Num At Risk
4
description
Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
EG003
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Part 1: GSK2857916 0.24 mg/kg
deaths Num Affected
0
deaths Num At Risk
4
description
Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
EG004
other Num Affected
3
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Part 1: GSK2857916 0.48 mg/kg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
EG005
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Part 1: GSK2857916 0.96 mg/kg
deaths Num Affected
0
deaths Num At Risk
4
description
Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
EG006
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Part 1: GSK2857916 1.92 mg/kg
deaths Num Affected
1
deaths Num At Risk
8
description
Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
EG007
other Num Affected
8
other Num At Risk
8
serious Num Affected
4
serious Num At Risk
8
title
Part 1: GSK2857916 2.50 mg/kg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
EG008
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part 1: GSK2857916 3.40 mg/kg
deaths Num Affected
1
deaths Num At Risk
6
description
Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
EG009
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Part 1: GSK2857916 4.60 mg/kg
deaths Num Affected
5
deaths Num At Risk
35
description
Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
id
EG010
other Num Affected
35
other Num At Risk
35
serious Num Affected
17
serious Num At Risk
35
title
Part 2: GSK2857916 3.40 mg/kg (MM)
deaths Num Affected
3
deaths Num At Risk
6
description
Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days).
id
EG011
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Part 2: GSK2857916 3.40 mg/kg (NHL)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
2
num At Risk
35
num Events
2
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
2
num At Risk
35
num Events
2
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
1
num At Risk
3
num Events
1
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Acne
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
2
group Id
EG010
num Affected
7
num At Risk
35
num Events
8
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Albuminuria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
4
num Events
1
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Alpha haemolytic streptococcal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
2
num At Risk
3
num Events
4
group Id
EG006
num Affected
1
num At Risk
4
num Events
1
group Id
EG007
num Affected
3
num At Risk
8
num Events
3
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
3
num At Risk
6
num Events
4
group Id
EG010
num Affected
10
num At Risk
35
num Events
12
group Id
EG011
num Affected
1
num At Risk
6
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Angina bullosa haemorrhagica
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
2
num At Risk
4
num Events
2
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
4
num Events
4
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
4
num At Risk
35
num Events
5
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
4
num Events
1
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
2
num At Risk
3
num Events
3
group Id
EG009
num Affected
4
num At Risk
6
num Events
5
group Id
EG010
num Affected
13
num At Risk
35
num Events
17
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Adenovirus infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
1
num At Risk
6
num Events
1
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Babesiosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Basal cell carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Cholecystitis infective
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
8
num Events
1
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
0
num At Risk
35
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Deep vein thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA22.1
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
8
num Events
0
group Id
EG008
num Affected
0
num At Risk
3
num Events
0
group Id
EG009
num Affected
0
num At Risk
6
num Events
0
group Id
EG010
num Affected
1
num At Risk
35
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Fall

time Frame

SAEs & common (>=5%) non-SAEs were collected from start of study treatment until 23.5 months for Part 1, 35 months for Part 2 (MM) and 7.2 months for Part 2 (NHL)

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

Preserved source evidence · Not medical advice