NCT02598661 · ADVERSE EVENTS

Adverse events

Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) · Source last updated 2026-07-17

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: Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy
Other-event reporting threshold: 5%

Safety Analysis Set=all participants who received at least 1 dose of study drug. Safety data for Phase 2 arm has been reported separately for the participants without dose escalation and with dose escalation from 7.5 mg/kg to 9.4 mg/kg. QTc Substudy: Crossover arm includes AEs data after crossover from placebo to Imetelstat. Placebo arm included AE data for participants randomized to placebo prior to crossover.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 2: Imetelstat Sodium (No Dose Escalation) Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.	26 / 50	50 / 50	24 / 50
Phase 2: Imetelstat Sodium (Escalated to 9.4 mg/kg) Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) with dose escalation to 9.4 mg/kg allowed before Protocol Amendment 2, until death, lost to follow up, withdrawal of consent, or study termination, whichever occurs first.	1 / 7	6 / 7	3 / 7
Phase 3: Imetelstat Sodium Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.	41 / 118	117 / 118	35 / 118
Phase 3: Placebo Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.	13 / 59	58 / 59	15 / 59
QTc Substudy: Imetelstat Sodium Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.	8 / 35	33 / 35	1 / 35
QTc Substudy: Crossover Imetelstat Sodium After a minimum of 2 treatment cycles (28-day cycle) if a participant had no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant was crossed over from placebo to receive imetelstat sodium 7.5 mg/kg.	3 / 14	12 / 14	0 / 14
QTc Substudy: Placebo Imetelstat sodium matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. If after a minimum of 2 treatment cycles a participant has no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant, he/she may be permitted to start treatment with imetelstat sodium.	0 / 18	13 / 18	0 / 18

Group identifiers: EG000: Phase 2: Imetelstat Sodium (No Dose Escalation) · EG001: Phase 2: Imetelstat Sodium (Escalated to 9.4 mg/kg) · EG002: Phase 3: Imetelstat Sodium · EG003: Phase 3: Placebo · EG004: QTc Substudy: Imetelstat Sodium · EG005: QTc Substudy: Crossover Imetelstat Sodium · EG006: QTc Substudy: Placebo

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 (25.0)
stats
group Id
EG000
num Affected
2
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
118
group Id
EG003
num Affected
1
num At Risk
59
group Id
EG004
num Affected
1
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Atypical pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
118
group Id
EG003
num Affected
3
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Cellulitis staphylococcal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Corynebacterium infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Dermo-hypodermitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Disseminated tuberculosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Escherichia bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Escherichia urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
1
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Sepsis

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 (25.0)
stats
group Id
EG000
num Affected
36
num At Risk
50
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
89
num At Risk
118
group Id
EG003
num Affected
5
num At Risk
59
group Id
EG004
num Affected
26
num At Risk
35
group Id
EG005
num Affected
8
num At Risk
14
group Id
EG006
num Affected
2
num At Risk
18
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
33
num At Risk
50
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
89
num At Risk
118
group Id
EG003
num Affected
6
num At Risk
59
group Id
EG004
num Affected
25
num At Risk
35
group Id
EG005
num Affected
9
num At Risk
14
group Id
EG006
num Affected
3
num At Risk
18
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
12
num At Risk
50
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
23
num At Risk
118
group Id
EG003
num Affected
7
num At Risk
59
group Id
EG004
num Affected
3
num At Risk
35
group Id
EG005
num Affected
1
num At Risk
14
group Id
EG006
num Affected
1
num At Risk
18
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
11
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
12
num At Risk
118
group Id
EG003
num Affected
1
num At Risk
59
group Id
EG004
num Affected
5
num At Risk
35
group Id
EG005
num Affected
3
num At Risk
14
group Id
EG006
num Affected
1
num At Risk
18
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
10
num At Risk
50
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
10
num At Risk
118
group Id
EG003
num Affected
7
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
1
num At Risk
18
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
7
num At Risk
50
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
15
num At Risk
118
group Id
EG003
num Affected
8
num At Risk
59
group Id
EG004
num Affected
3
num At Risk
35
group Id
EG005
num Affected
2
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
5
num At Risk
50
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
9
num At Risk
118
group Id
EG003
num Affected
4
num At Risk
59
group Id
EG004
num Affected
5
num At Risk
35
group Id
EG005
num Affected
2
num At Risk
14
group Id
EG006
num Affected
1
num At Risk
18
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
4
num At Risk
50
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
21
num At Risk
118
group Id
EG003
num Affected
8
num At Risk
59
group Id
EG004
num Affected
2
num At Risk
35
group Id
EG005
num Affected
1
num At Risk
14
group Id
EG006
num Affected
1
num At Risk
18
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
2
num At Risk
50
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
2
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
3
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
1
num At Risk
35
group Id
EG005
num Affected
1
num At Risk
14
group Id
EG006
num Affected
1
num At Risk
18
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
10
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
7
num At Risk
118
group Id
EG003
num Affected
2
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
6
num At Risk
50
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Nasopharyngitis

Complete source fields

description

event Groups

deaths Num Affected
24
deaths Num At Risk
50
description
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
id
EG000
other Num Affected
50
other Num At Risk
50
serious Num Affected
26
serious Num At Risk
50
title
Phase 2: Imetelstat Sodium (No Dose Escalation)
deaths Num Affected
3
deaths Num At Risk
7
description
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) with dose escalation to 9.4 mg/kg allowed before Protocol Amendment 2, until death, lost to follow up, withdrawal of consent, or study termination, whichever occurs first.
id
EG001
other Num Affected
6
other Num At Risk
7
serious Num Affected
1
serious Num At Risk
7
title
Phase 2: Imetelstat Sodium (Escalated to 9.4 mg/kg)
deaths Num Affected
35
deaths Num At Risk
118
description
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
id
EG002
other Num Affected
117
other Num At Risk
118
serious Num Affected
41
serious Num At Risk
118
title
Phase 3: Imetelstat Sodium
deaths Num Affected
15
deaths Num At Risk
59
description
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
id
EG003
other Num Affected
58
other Num At Risk
59
serious Num Affected
13
serious Num At Risk
59
title
Phase 3: Placebo
deaths Num Affected
1
deaths Num At Risk
35
description
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
id
EG004
other Num Affected
33
other Num At Risk
35
serious Num Affected
8
serious Num At Risk
35
title
QTc Substudy: Imetelstat Sodium
deaths Num Affected
0
deaths Num At Risk
14
description
After a minimum of 2 treatment cycles (28-day cycle) if a participant had no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant was crossed over from placebo to receive imetelstat sodium 7.5 mg/kg.
id
EG005
other Num Affected
12
other Num At Risk
14
serious Num Affected
3
serious Num At Risk
14
title
QTc Substudy: Crossover Imetelstat Sodium
deaths Num Affected
0
deaths Num At Risk
18
description
Imetelstat sodium matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. If after a minimum of 2 treatment cycles a participant has no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant, he/she may be permitted to start treatment with imetelstat sodium.
id
EG006
other Num Affected
13
other Num At Risk
18
serious Num Affected
0
serious Num At Risk
18
title
QTc Substudy: Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
36
num At Risk
50
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
89
num At Risk
118
group Id
EG003
num Affected
5
num At Risk
59
group Id
EG004
num Affected
26
num At Risk
35
group Id
EG005
num Affected
8
num At Risk
14
group Id
EG006
num Affected
2
num At Risk
18
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
33
num At Risk
50
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
89
num At Risk
118
group Id
EG003
num Affected
6
num At Risk
59
group Id
EG004
num Affected
25
num At Risk
35
group Id
EG005
num Affected
9
num At Risk
14
group Id
EG006
num Affected
3
num At Risk
18
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
12
num At Risk
50
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
23
num At Risk
118
group Id
EG003
num Affected
7
num At Risk
59
group Id
EG004
num Affected
3
num At Risk
35
group Id
EG005
num Affected
1
num At Risk
14
group Id
EG006
num Affected
1
num At Risk
18
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
11
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
12
num At Risk
118
group Id
EG003
num Affected
1
num At Risk
59
group Id
EG004
num Affected
5
num At Risk
35
group Id
EG005
num Affected
3
num At Risk
14
group Id
EG006
num Affected
1
num At Risk
18
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
10
num At Risk
50
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
10
num At Risk
118
group Id
EG003
num Affected
7
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
1
num At Risk
18
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
7
num At Risk
50
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
15
num At Risk
118
group Id
EG003
num Affected
8
num At Risk
59
group Id
EG004
num Affected
3
num At Risk
35
group Id
EG005
num Affected
2
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
5
num At Risk
50
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
9
num At Risk
118
group Id
EG003
num Affected
4
num At Risk
59
group Id
EG004
num Affected
5
num At Risk
35
group Id
EG005
num Affected
2
num At Risk
14
group Id
EG006
num Affected
1
num At Risk
18
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
4
num At Risk
50
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
21
num At Risk
118
group Id
EG003
num Affected
8
num At Risk
59
group Id
EG004
num Affected
2
num At Risk
35
group Id
EG005
num Affected
1
num At Risk
14
group Id
EG006
num Affected
1
num At Risk
18
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
2
num At Risk
50
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
2
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
3
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
1
num At Risk
35
group Id
EG005
num Affected
1
num At Risk
14
group Id
EG006
num Affected
1
num At Risk
18
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
10
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
7
num At Risk
118
group Id
EG003
num Affected
2
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
6
num At Risk
50
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Nasopharyngitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
2
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
118
group Id
EG003
num Affected
1
num At Risk
59
group Id
EG004
num Affected
1
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Atypical pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
118
group Id
EG003
num Affected
3
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Cellulitis staphylococcal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Corynebacterium infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Dermo-hypodermitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Disseminated tuberculosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Escherichia bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
0
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Escherichia urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
50
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
118
group Id
EG003
num Affected
0
num At Risk
59
group Id
EG004
num Affected
0
num At Risk
35
group Id
EG005
num Affected
1
num At Risk
14
group Id
EG006
num Affected
0
num At Risk
18
term
Sepsis

time Frame

Adverse events: Up to 5 years in Phase 2; up to 3.7 years in Phase 3; up to 1.3 years in QTc substudy; All-cause mortality: Up to 6.6 years in Phase 2; up to 4 years in Phase 3; up to 1.6 years in QTc substudy

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

Preserved source evidence · Not medical advice