NCT01850524 · ADVERSE EVENTS

Adverse events

IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2023-07-21

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 date of randomization through 30 days after the last dose of study drug up to end of study (up to approximately 9 years)
Other-event reporting threshold: 5%

Safety population included all participants who received at least 1 dose of any drug. 4 participants who were randomized to the placebo received ixazomib during the study and were included in the ixazomib arm for the safety population. 1 participant randomized to each arm withdrew from the study and were not included in the safety population. Data for safety is summarized as per the duration of exposure to study treatment (exposure up to 18 cycles; exposure ≥19 cycles).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo + LenDex (Exposure Up to 18 Cycles) Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).	105 / 160	159 / 160	107 / 160
Ixazomib+ LenDex (Exposure Up to 18 Cycles) Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).	119 / 163	162 / 163	95 / 163
Placebo + LenDex (Exposure ≥19 Cycles) Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib placebo matching capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).	119 / 189	189 / 189	63 / 189
Ixazomib + LenDex (Exposure ≥19 Cycles) Participants who were randomly assigned to receive Ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).	125 / 191	191 / 191	63 / 191

Group identifiers: EG000: Placebo + LenDex (Exposure Up to 18 Cycles) · EG001: Ixazomib+ LenDex (Exposure Up to 18 Cycles) · EG002: Placebo + LenDex (Exposure ≥19 Cycles) · EG003: Ixazomib + LenDex (Exposure ≥19 Cycles)

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: 22.0
stats
group Id
EG000
num Affected
16
num At Risk
160
group Id
EG001
num Affected
22
num At Risk
163
group Id
EG002
num Affected
13
num At Risk
189
group Id
EG003
num Affected
22
num At Risk
191
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
0
num At Risk
160
group Id
EG001
num Affected
3
num At Risk
163
group Id
EG002
num Affected
5
num At Risk
189
group Id
EG003
num Affected
4
num At Risk
191
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
2
num At Risk
160
group Id
EG001
num Affected
1
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
0
num At Risk
160
group Id
EG001
num Affected
0
num At Risk
163
group Id
EG002
num Affected
1
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Atypical pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
1
num At Risk
160
group Id
EG001
num Affected
0
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Pleural infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
4
num At Risk
160
group Id
EG001
num Affected
4
num At Risk
163
group Id
EG002
num Affected
4
num At Risk
189
group Id
EG003
num Affected
1
num At Risk
191
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
4
num At Risk
160
group Id
EG001
num Affected
4
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
0
num At Risk
160
group Id
EG001
num Affected
0
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
1
num At Risk
191
term
Pulmonary sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
1
num At Risk
160
group Id
EG001
num Affected
0
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Sepsis syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
1
num At Risk
160
group Id
EG001
num Affected
0
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Urosepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
1
num At Risk
160
group Id
EG001
num Affected
3
num At Risk
163
group Id
EG002
num Affected
3
num At Risk
189
group Id
EG003
num Affected
6
num At Risk
191
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
0
num At Risk
160
group Id
EG001
num Affected
1
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Pyelonephritis

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: 22.0
stats
group Id
EG000
num Affected
52
num At Risk
160
group Id
EG001
num Affected
66
num At Risk
163
group Id
EG002
num Affected
64
num At Risk
189
group Id
EG003
num Affected
106
num At Risk
191
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
53
num At Risk
160
group Id
EG001
num Affected
41
num At Risk
163
group Id
EG002
num Affected
52
num At Risk
189
group Id
EG003
num Affected
69
num At Risk
191
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
44
num At Risk
160
group Id
EG001
num Affected
36
num At Risk
163
group Id
EG002
num Affected
53
num At Risk
189
group Id
EG003
num Affected
58
num At Risk
191
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
20
num At Risk
160
group Id
EG001
num Affected
30
num At Risk
163
group Id
EG002
num Affected
29
num At Risk
189
group Id
EG003
num Affected
33
num At Risk
191
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
8
num At Risk
160
group Id
EG001
num Affected
8
num At Risk
163
group Id
EG002
num Affected
12
num At Risk
189
group Id
EG003
num Affected
17
num At Risk
191
term
Peripheral swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
3
num At Risk
160
group Id
EG001
num Affected
6
num At Risk
163
group Id
EG002
num Affected
16
num At Risk
189
group Id
EG003
num Affected
17
num At Risk
191
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
4
num At Risk
160
group Id
EG001
num Affected
1
num At Risk
163
group Id
EG002
num Affected
11
num At Risk
189
group Id
EG003
num Affected
16
num At Risk
191
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
2
num At Risk
160
group Id
EG001
num Affected
4
num At Risk
163
group Id
EG002
num Affected
10
num At Risk
189
group Id
EG003
num Affected
14
num At Risk
191
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
10
num At Risk
160
group Id
EG001
num Affected
11
num At Risk
163
group Id
EG002
num Affected
7
num At Risk
189
group Id
EG003
num Affected
12
num At Risk
191
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
48
num At Risk
160
group Id
EG001
num Affected
68
num At Risk
163
group Id
EG002
num Affected
115
num At Risk
189
group Id
EG003
num Affected
147
num At Risk
191
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
61
num At Risk
160
group Id
EG001
num Affected
59
num At Risk
163
group Id
EG002
num Affected
82
num At Risk
189
group Id
EG003
num Affected
92
num At Risk
191
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
35
num At Risk
160
group Id
EG001
num Affected
55
num At Risk
163
group Id
EG002
num Affected
63
num At Risk
189
group Id
EG003
num Affected
78
num At Risk
191
term
Nausea

Complete source fields

description

event Groups

deaths Num Affected
107
deaths Num At Risk
160
description
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).
id
EG000
other Num Affected
159
other Num At Risk
160
serious Num Affected
105
serious Num At Risk
160
title
Placebo + LenDex (Exposure Up to 18 Cycles)
deaths Num Affected
95
deaths Num At Risk
163
description
Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).
id
EG001
other Num Affected
162
other Num At Risk
163
serious Num Affected
119
serious Num At Risk
163
title
Ixazomib+ LenDex (Exposure Up to 18 Cycles)
deaths Num Affected
63
deaths Num At Risk
189
description
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib placebo matching capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
id
EG002
other Num Affected
189
other Num At Risk
189
serious Num Affected
119
serious Num At Risk
189
title
Placebo + LenDex (Exposure ≥19 Cycles)
deaths Num Affected
63
deaths Num At Risk
191
description
Participants who were randomly assigned to receive Ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
id
EG003
other Num Affected
191
other Num At Risk
191
serious Num Affected
125
serious Num At Risk
191
title
Ixazomib + LenDex (Exposure ≥19 Cycles)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
52
num At Risk
160
group Id
EG001
num Affected
66
num At Risk
163
group Id
EG002
num Affected
64
num At Risk
189
group Id
EG003
num Affected
106
num At Risk
191
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
53
num At Risk
160
group Id
EG001
num Affected
41
num At Risk
163
group Id
EG002
num Affected
52
num At Risk
189
group Id
EG003
num Affected
69
num At Risk
191
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
44
num At Risk
160
group Id
EG001
num Affected
36
num At Risk
163
group Id
EG002
num Affected
53
num At Risk
189
group Id
EG003
num Affected
58
num At Risk
191
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
20
num At Risk
160
group Id
EG001
num Affected
30
num At Risk
163
group Id
EG002
num Affected
29
num At Risk
189
group Id
EG003
num Affected
33
num At Risk
191
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
8
num At Risk
160
group Id
EG001
num Affected
8
num At Risk
163
group Id
EG002
num Affected
12
num At Risk
189
group Id
EG003
num Affected
17
num At Risk
191
term
Peripheral swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
3
num At Risk
160
group Id
EG001
num Affected
6
num At Risk
163
group Id
EG002
num Affected
16
num At Risk
189
group Id
EG003
num Affected
17
num At Risk
191
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
4
num At Risk
160
group Id
EG001
num Affected
1
num At Risk
163
group Id
EG002
num Affected
11
num At Risk
189
group Id
EG003
num Affected
16
num At Risk
191
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
2
num At Risk
160
group Id
EG001
num Affected
4
num At Risk
163
group Id
EG002
num Affected
10
num At Risk
189
group Id
EG003
num Affected
14
num At Risk
191
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
10
num At Risk
160
group Id
EG001
num Affected
11
num At Risk
163
group Id
EG002
num Affected
7
num At Risk
189
group Id
EG003
num Affected
12
num At Risk
191
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
48
num At Risk
160
group Id
EG001
num Affected
68
num At Risk
163
group Id
EG002
num Affected
115
num At Risk
189
group Id
EG003
num Affected
147
num At Risk
191
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
61
num At Risk
160
group Id
EG001
num Affected
59
num At Risk
163
group Id
EG002
num Affected
82
num At Risk
189
group Id
EG003
num Affected
92
num At Risk
191
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
35
num At Risk
160
group Id
EG001
num Affected
55
num At Risk
163
group Id
EG002
num Affected
63
num At Risk
189
group Id
EG003
num Affected
78
num At Risk
191
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
16
num At Risk
160
group Id
EG001
num Affected
22
num At Risk
163
group Id
EG002
num Affected
13
num At Risk
189
group Id
EG003
num Affected
22
num At Risk
191
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
0
num At Risk
160
group Id
EG001
num Affected
3
num At Risk
163
group Id
EG002
num Affected
5
num At Risk
189
group Id
EG003
num Affected
4
num At Risk
191
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
2
num At Risk
160
group Id
EG001
num Affected
1
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
0
num At Risk
160
group Id
EG001
num Affected
0
num At Risk
163
group Id
EG002
num Affected
1
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Atypical pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
1
num At Risk
160
group Id
EG001
num Affected
0
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Pleural infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
4
num At Risk
160
group Id
EG001
num Affected
4
num At Risk
163
group Id
EG002
num Affected
4
num At Risk
189
group Id
EG003
num Affected
1
num At Risk
191
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
4
num At Risk
160
group Id
EG001
num Affected
4
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
0
num At Risk
160
group Id
EG001
num Affected
0
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
1
num At Risk
191
term
Pulmonary sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
1
num At Risk
160
group Id
EG001
num Affected
0
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Sepsis syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
1
num At Risk
160
group Id
EG001
num Affected
0
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Urosepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
1
num At Risk
160
group Id
EG001
num Affected
3
num At Risk
163
group Id
EG002
num Affected
3
num At Risk
189
group Id
EG003
num Affected
6
num At Risk
191
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA: 22.0
stats
group Id
EG000
num Affected
0
num At Risk
160
group Id
EG001
num Affected
1
num At Risk
163
group Id
EG002
num Affected
0
num At Risk
189
group Id
EG003
num Affected
0
num At Risk
191
term
Pyelonephritis

time Frame

From the date of randomization through 30 days after the last dose of study drug up to end of study (up to approximately 9 years)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice