NCT00932698 · ADVERSE EVENTS

Adverse events

Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple Myeloma · Source last updated 2019-08-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
Other-event reporting threshold: 5%

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).	0 / 3	3 / 3	0 / 3
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).	0 / 3	3 / 3	0 / 3
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).	2 / 3	3 / 3	1 / 3
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).	2 / 3	3 / 3	0 / 3
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).	0 / 3	3 / 3	0 / 3
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).	5 / 7	7 / 7	0 / 7
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).	3 / 4	4 / 4	0 / 4
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).	14 / 20	20 / 20	1 / 20
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).	6 / 12	12 / 12	0 / 12
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days).	3 / 6	6 / 6	0 / 6
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).	2 / 2	2 / 2	0 / 2

Group identifiers: EG000: Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 · EG001: Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 · EG002: Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 · EG003: Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 · EG004: Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 · EG005: Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 · EG006: Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 · EG007: Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 · EG008: Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 · EG009: Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 · EG010: Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2

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 (15.0)
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
3
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
2
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
3
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Hyperviscosity syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
2
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
2
num At Risk
2
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
2
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Staphylococcal skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (15.0)
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
3
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
1
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
2
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
2
term
Hypercalcaemia

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
General disorders
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
4
num At Risk
7
group Id
EG006
num Affected
2
num At Risk
4
group Id
EG007
num Affected
12
num At Risk
20
group Id
EG008
num Affected
8
num At Risk
12
group Id
EG009
num Affected
2
num At Risk
6
group Id
EG010
num Affected
2
num At Risk
2
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
4
num At Risk
20
group Id
EG008
num Affected
2
num At Risk
12
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Application site erythema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Face oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Feeling abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Mucosal dryness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Nodule
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (15.0)
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
1
num At Risk
3
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
2
num At Risk
7
group Id
EG006
num Affected
2
num At Risk
4
group Id
EG007
num Affected
4
num At Risk
20
group Id
EG008
num Affected
2
num At Risk
12
group Id
EG009
num Affected
3
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
2
term
Rash macular

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
deaths Num Affected
0
deaths Num At Risk
3
description
Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
deaths Num Affected
1
deaths Num At Risk
3
description
Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
deaths Num Affected
0
deaths Num At Risk
3
description
Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
deaths Num Affected
0
deaths Num At Risk
3
description
Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
deaths Num Affected
0
deaths Num At Risk
7
description
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
id
EG005
other Num Affected
7
other Num At Risk
7
serious Num Affected
5
serious Num At Risk
7
title
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
deaths Num Affected
0
deaths Num At Risk
4
description
Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
id
EG006
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
deaths Num Affected
1
deaths Num At Risk
20
description
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
id
EG007
other Num Affected
20
other Num At Risk
20
serious Num Affected
14
serious Num At Risk
20
title
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
deaths Num Affected
0
deaths Num At Risk
12
description
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
id
EG008
other Num Affected
12
other Num At Risk
12
serious Num Affected
6
serious Num At Risk
12
title
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2
deaths Num Affected
0
deaths Num At Risk
6
description
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days).
id
EG009
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
deaths Num Affected
0
deaths Num At Risk
2
description
Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
id
EG010
other Num Affected
2
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
4
num At Risk
7
group Id
EG006
num Affected
2
num At Risk
4
group Id
EG007
num Affected
12
num At Risk
20
group Id
EG008
num Affected
8
num At Risk
12
group Id
EG009
num Affected
2
num At Risk
6
group Id
EG010
num Affected
2
num At Risk
2
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
1
num At Risk
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
4
num At Risk
20
group Id
EG008
num Affected
2
num At Risk
12
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Application site erythema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Face oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Feeling abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Mucosal dryness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Nodule
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (15.0)
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
1
num At Risk
3
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
2
num At Risk
7
group Id
EG006
num Affected
2
num At Risk
4
group Id
EG007
num Affected
4
num At Risk
20
group Id
EG008
num Affected
2
num At Risk
12
group Id
EG009
num Affected
3
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
2
term
Rash macular

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (15.0)
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
3
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
2
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
3
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
2
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Hyperviscosity syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
2
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
2
num At Risk
2
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
2
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Staphylococcal skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
1
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (15.0)
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
3
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
1
num At Risk
7
group Id
EG006
num Affected
1
num At Risk
4
group Id
EG007
num Affected
2
num At Risk
20
group Id
EG008
num Affected
1
num At Risk
12
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
2
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (15.0)
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
3
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
7
group Id
EG006
num Affected
0
num At Risk
4
group Id
EG007
num Affected
0
num At Risk
20
group Id
EG008
num Affected
0
num At Risk
12
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
2
term
Hypercalcaemia

time Frame

From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)

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

Preserved source evidence · Not medical advice