NCT01897714 · ADVERSE EVENTS

Adverse events

Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients · Source last updated 2020-10-23

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 the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months.
Other-event reporting threshold: 0%

The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I: Melflufen 15 mg + Dexamethasone Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	3 / 4	4 / 4	3 / 4
Phase I: Melflufen 25 mg + Dexamethasone Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	4 / 7	7 / 7	5 / 7
Phase I: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	2 / 6	6 / 6	2 / 6
Phase I: Melflufen 55 mg + Dexamethasone Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	4 / 6	6 / 6	5 / 6
Phase I + II: Melflufen 40 mg + Dexamethasone Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.	17 / 45	45 / 45	30 / 45
Phase II: Melflufen 40 mg (Single Agent) Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.	9 / 13	12 / 13	10 / 13

Group identifiers: EG000: Phase I: Melflufen 15 mg + Dexamethasone · EG001: Phase I: Melflufen 25 mg + Dexamethasone · EG002: Phase I: Melflufen 40 mg + Dexamethasone · EG003: Phase I: Melflufen 55 mg + Dexamethasone · EG004: Phase I + II: Melflufen 40 mg + Dexamethasone · EG005: Phase II: Melflufen 40 mg (Single Agent)

Serious adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
5
num At Risk
45
num Events
5
group Id
EG005
num Affected
1
num At Risk
13
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Cystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Escherichia bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
3
num At Risk
6
num Events
3
group Id
EG004
num Affected
2
num At Risk
45
num Events
2
group Id
EG005
num Affected
1
num At Risk
13
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
2
num At Risk
45
num Events
2
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Arthralgia

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 20.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
6
num At Risk
7
num Events
9
group Id
EG002
num Affected
4
num At Risk
6
num Events
26
group Id
EG003
num Affected
5
num At Risk
6
num Events
35
group Id
EG004
num Affected
33
num At Risk
45
num Events
154
group Id
EG005
num Affected
9
num At Risk
13
num Events
30
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
3
num At Risk
7
num Events
7
group Id
EG002
num Affected
3
num At Risk
6
num Events
12
group Id
EG003
num Affected
6
num At Risk
6
num Events
26
group Id
EG004
num Affected
31
num At Risk
45
num Events
115
group Id
EG005
num Affected
9
num At Risk
13
num Events
25
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
4
num At Risk
7
num Events
5
group Id
EG002
num Affected
2
num At Risk
6
num Events
4
group Id
EG003
num Affected
3
num At Risk
6
num Events
6
group Id
EG004
num Affected
29
num At Risk
45
num Events
96
group Id
EG005
num Affected
5
num At Risk
13
num Events
14
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
3
num At Risk
45
num Events
3
group Id
EG005
num Affected
1
num At Risk
13
num Events
3
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
45
num Events
1
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
1
num At Risk
45
num Events
1
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Anaemia vitamin B12 deficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Increased tendency to bruise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
4
num At Risk
6
num Events
6
group Id
EG003
num Affected
4
num At Risk
6
num Events
5
group Id
EG004
num Affected
12
num At Risk
45
num Events
14
group Id
EG005
num Affected
2
num At Risk
13
num Events
3
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
3
num At Risk
7
num Events
3
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
7
num At Risk
45
num Events
8
group Id
EG005
num Affected
1
num At Risk
13
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
3
group Id
EG003
num Affected
4
num At Risk
6
num Events
5
group Id
EG004
num Affected
9
num At Risk
45
num Events
10
group Id
EG005
num Affected
2
num At Risk
13
num Events
2
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
5
num At Risk
45
num Events
5
group Id
EG005
num Affected
1
num At Risk
13
num Events
1
term
Vomiting

Complete source fields

description

The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.

event Groups

deaths Num Affected
3
deaths Num At Risk
4
description
Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Phase I: Melflufen 15 mg + Dexamethasone
deaths Num Affected
5
deaths Num At Risk
7
description
Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
id
EG001
other Num Affected
7
other Num At Risk
7
serious Num Affected
4
serious Num At Risk
7
title
Phase I: Melflufen 25 mg + Dexamethasone
deaths Num Affected
2
deaths Num At Risk
6
description
Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
id
EG002
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Phase I: Melflufen 40 mg + Dexamethasone
deaths Num Affected
5
deaths Num At Risk
6
description
Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Phase I: Melflufen 55 mg + Dexamethasone
deaths Num Affected
30
deaths Num At Risk
45
description
Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.
id
EG004
other Num Affected
45
other Num At Risk
45
serious Num Affected
17
serious Num At Risk
45
title
Phase I + II: Melflufen 40 mg + Dexamethasone
deaths Num Affected
10
deaths Num At Risk
13
description
Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
id
EG005
other Num Affected
12
other Num At Risk
13
serious Num Affected
9
serious Num At Risk
13
title
Phase II: Melflufen 40 mg (Single Agent)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
6
num At Risk
7
num Events
9
group Id
EG002
num Affected
4
num At Risk
6
num Events
26
group Id
EG003
num Affected
5
num At Risk
6
num Events
35
group Id
EG004
num Affected
33
num At Risk
45
num Events
154
group Id
EG005
num Affected
9
num At Risk
13
num Events
30
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
3
num At Risk
7
num Events
7
group Id
EG002
num Affected
3
num At Risk
6
num Events
12
group Id
EG003
num Affected
6
num At Risk
6
num Events
26
group Id
EG004
num Affected
31
num At Risk
45
num Events
115
group Id
EG005
num Affected
9
num At Risk
13
num Events
25
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
4
num At Risk
7
num Events
5
group Id
EG002
num Affected
2
num At Risk
6
num Events
4
group Id
EG003
num Affected
3
num At Risk
6
num Events
6
group Id
EG004
num Affected
29
num At Risk
45
num Events
96
group Id
EG005
num Affected
5
num At Risk
13
num Events
14
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
3
num At Risk
45
num Events
3
group Id
EG005
num Affected
1
num At Risk
13
num Events
3
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
45
num Events
1
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
1
num At Risk
45
num Events
1
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Anaemia vitamin B12 deficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Increased tendency to bruise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
4
num At Risk
6
num Events
6
group Id
EG003
num Affected
4
num At Risk
6
num Events
5
group Id
EG004
num Affected
12
num At Risk
45
num Events
14
group Id
EG005
num Affected
2
num At Risk
13
num Events
3
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
3
num At Risk
7
num Events
3
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
7
num At Risk
45
num Events
8
group Id
EG005
num Affected
1
num At Risk
13
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
3
group Id
EG003
num Affected
4
num At Risk
6
num Events
5
group Id
EG004
num Affected
9
num At Risk
45
num Events
10
group Id
EG005
num Affected
2
num At Risk
13
num Events
2
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
5
num At Risk
45
num Events
5
group Id
EG005
num Affected
1
num At Risk
13
num Events
1
term
Vomiting

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
5
num At Risk
45
num Events
5
group Id
EG005
num Affected
1
num At Risk
13
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Cystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Escherichia bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
3
num At Risk
6
num Events
3
group Id
EG004
num Affected
2
num At Risk
45
num Events
2
group Id
EG005
num Affected
1
num At Risk
13
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
2
num At Risk
45
num Events
2
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
45
num Events
0
group Id
EG005
num Affected
0
num At Risk
13
num Events
0
term
Arthralgia

time Frame

From the first dose of study drug up to and including the actual EOT date of 29 October 2019; up to a maximum of approximately 76 months.

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

Preserved source evidence · Not medical advice