NCT02009449 · ADVERSE EVENTS

Adverse events

A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors · Source last updated 2026-07-09

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 study drug through 30 days after the last dose of study drug (Up to 116 Months)
Other-event reporting threshold: 0%

Participants who received at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected and reported by treatment regimen. Gender specific events only occurring in male or female participants have had the number of participants "At Risk" adjusted accordingly.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part A: Pegilodecakin 0.08/0.1 mg Participants received 0.08 or 0.1 mg of Pegilodecakin once daily (QD) administered subcutaneously (SC). Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	3 / 4	4 / 4	4 / 4
Part A: Pegilodecakin 0.2/0.25 mg Participants received 0.2 or 0.25 mg dose of Pegilodecakin QD administered SC Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	2 / 6	6 / 6	6 / 6
Part A: Pegilodecakin 0.4/0.5 mg Participants received 0.4 or 0.5 mg dose of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	2 / 6	6 / 6	6 / 6
Part A: Pegilodecakin 0.8/1 mg Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	2 / 6	6 / 6	6 / 6
Part A: Pegilodecakin 1.6/2 mg Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	60 / 117	116 / 117	105 / 117
Part A: Pegilodecakin 3.2/4 mg Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	2 / 5	5 / 5	5 / 5
Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	0 / 4	4 / 4	4 / 4
Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	1 / 3	3 / 3	3 / 3
Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	10 / 18	18 / 18	14 / 18
Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX Participants received 0.2 or 0.25 mg dose of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	3 / 4	4 / 4	4 / 4
Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	14 / 29	29 / 29	27 / 29
Part C: Pegilodecakin 0.8/1 mg + FOLFOX Participants received 0.8 or 1 mg dose of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	3 / 6	6 / 6	6 / 6
Part D: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Nab-Paclitaxel Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with Gemcitabine 1000 mg/m2 IV over 30 minutes plus nab-paclitaxel 125 mg/m2 IV over 30 to 40 minutes on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	2 / 6	6 / 6	6 / 6
Part E: Pegilodecakin 0.8/1 mg + Capecitabine Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Capecitabine 1000 mg/m² orally twice daily (BID) on Days 1 through 14 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	4 / 6	6 / 6	6 / 6
Part F: Pegilodecakin 0.8/1 mg + Paclitaxel Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Paclitaxel 80 mg/m2 IV over 3 hours on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	4 / 6	6 / 6	6 / 6
Part G: Pegilodecakin 0.8/1 mg + Pazopanib Participants received a 0.8 or 1 mg of Pegilodecakin QD administered SC with Pazopanib 800 mg orally QD. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	1 / 6	6 / 6	4 / 6
Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	8 / 14	14 / 14	8 / 14
Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	16 / 34	34 / 34	29 / 34
Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	3 / 5	5 / 5	3 / 5
Part I: Pegilodecakin 0.8/1 mg + Nivolumab Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	1 / 1	1 / 1	0 / 1
Part I: Pegilodecakin 1.6/2 mg + Nivolumab Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	32 / 57	56 / 57	33 / 57
Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an AUC2 IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	2 / 5	5 / 5	5 / 5
Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an AUC2 IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.	1 / 5	5 / 5	5 / 5

Group identifiers: EG000: Part A: Pegilodecakin 0.08/0.1 mg · EG001: Part A: Pegilodecakin 0.2/0.25 mg · EG002: Part A: Pegilodecakin 0.4/0.5 mg · EG003: Part A: Pegilodecakin 0.8/1 mg · EG004: Part A: Pegilodecakin 1.6/2 mg · EG005: Part A: Pegilodecakin 3.2/4 mg · EG006: Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane · EG007: Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane · EG008: Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane · EG009: Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX · EG010: Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX · EG011: Part C: Pegilodecakin 0.8/1 mg + FOLFOX · EG012: Part D: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Nab-Paclitaxel · EG013: Part E: Pegilodecakin 0.8/1 mg + Capecitabine · EG014: Part F: Pegilodecakin 0.8/1 mg + Paclitaxel · EG015: Part G: Pegilodecakin 0.8/1 mg + Pazopanib · EG016: Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab · EG017: Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab · EG018: Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab · EG019: Part I: Pegilodecakin 0.8/1 mg + Nivolumab · EG020: Part I: Pegilodecakin 1.6/2 mg + Nivolumab · EG021: Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin · EG022: Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin

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 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
8
num At Risk
117
num Events
8
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
2
num At Risk
18
num Events
2
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
2
num At Risk
29
num Events
2
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
2
num At Risk
18
num Events
2
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
1
num At Risk
117
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
1
num At Risk
117
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
1
num At Risk
29
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Cardiac failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
1
num At Risk
117
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Sinus tachycardia

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 28.1
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
3
num At Risk
6
num Events
3
group Id
EG002
num Affected
5
num At Risk
6
num Events
5
group Id
EG003
num Affected
5
num At Risk
6
num Events
5
group Id
EG004
num Affected
88
num At Risk
117
num Events
88
group Id
EG005
num Affected
4
num At Risk
5
num Events
4
group Id
EG006
num Affected
3
num At Risk
4
num Events
3
group Id
EG007
num Affected
3
num At Risk
3
num Events
3
group Id
EG008
num Affected
14
num At Risk
18
num Events
14
group Id
EG009
num Affected
2
num At Risk
4
num Events
2
group Id
EG010
num Affected
19
num At Risk
29
num Events
19
group Id
EG011
num Affected
4
num At Risk
6
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Anisocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
1
num At Risk
117
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Increased tendency to bruise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
3
num At Risk
117
num Events
3
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
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
9
num At Risk
117
num Events
9
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
5
num At Risk
18
num Events
5
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
1
num At Risk
29
num Events
1
group Id
EG011
num Affected
2
num At Risk
6
num Events
2
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
4
num At Risk
117
num Events
4
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
7
num At Risk
29
num Events
7
group Id
EG011
num Affected
2
num At Risk
6
num Events
2
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
1
num At Risk
117
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
2
num At Risk
117
num Events
2
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
4
num At Risk
4
num Events
4
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
7
num At Risk
18
num Events
7
group Id
EG009
num Affected
2
num At Risk
4
num Events
2
group Id
EG010
num Affected
15
num At Risk
29
num Events
15
group Id
EG011
num Affected
3
num At Risk
6
num Events
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Splenomegaly
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
69
num At Risk
117
num Events
69
group Id
EG005
num Affected
3
num At Risk
5
num Events
3
group Id
EG006
num Affected
3
num At Risk
4
num Events
3
group Id
EG007
num Affected
2
num At Risk
3
num Events
2
group Id
EG008
num Affected
14
num At Risk
18
num Events
14
group Id
EG009
num Affected
2
num At Risk
4
num Events
2
group Id
EG010
num Affected
23
num At Risk
29
num Events
23
group Id
EG011
num Affected
5
num At Risk
6
num Events
5
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Angina pectoris

Complete source fields

description

event Groups

deaths Num Affected
4
deaths Num At Risk
4
description
Participants received 0.08 or 0.1 mg of Pegilodecakin once daily (QD) administered subcutaneously (SC). Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Part A: Pegilodecakin 0.08/0.1 mg
deaths Num Affected
6
deaths Num At Risk
6
description
Participants received 0.2 or 0.25 mg dose of Pegilodecakin QD administered SC Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Part A: Pegilodecakin 0.2/0.25 mg
deaths Num Affected
6
deaths Num At Risk
6
description
Participants received 0.4 or 0.5 mg dose of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
id
EG002
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Part A: Pegilodecakin 0.4/0.5 mg
deaths Num Affected
6
deaths Num At Risk
6
description
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Part A: Pegilodecakin 0.8/1 mg
deaths Num Affected
105
deaths Num At Risk
117
description
Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
id
EG004
other Num Affected
116
other Num At Risk
117
serious Num Affected
60
serious Num At Risk
117
title
Part A: Pegilodecakin 1.6/2 mg
deaths Num Affected
5
deaths Num At Risk
5
description
Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
id
EG005
other Num Affected
5
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
Part A: Pegilodecakin 3.2/4 mg
deaths Num Affected
4
deaths Num At Risk
4
description
Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
id
EG006
other Num Affected
4
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane
deaths Num Affected
3
deaths Num At Risk
3
description
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
id
EG007
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane
deaths Num Affected
14
deaths Num At Risk
18
description
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
id
EG008
other Num Affected
18
other Num At Risk
18
serious Num Affected
10
serious Num At Risk
18
title
Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane
deaths Num Affected
4
deaths Num At Risk
4
description
Participants received 0.2 or 0.25 mg dose of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
id
EG009
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX
deaths Num Affected
27
deaths Num At Risk
29
description
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
id
EG010
other Num Affected
29
other Num At Risk
29
serious Num Affected
14
serious Num At Risk
29
title
Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX
deaths Num Affected
6
deaths Num At Risk
6
description
Participants received 0.8 or 1 mg dose of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
id
EG011
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Part C: Pegilodecakin 0.8/1 mg + FOLFOX

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
3
num At Risk
6
num Events
3
group Id
EG002
num Affected
5
num At Risk
6
num Events
5
group Id
EG003
num Affected
5
num At Risk
6
num Events
5
group Id
EG004
num Affected
88
num At Risk
117
num Events
88
group Id
EG005
num Affected
4
num At Risk
5
num Events
4
group Id
EG006
num Affected
3
num At Risk
4
num Events
3
group Id
EG007
num Affected
3
num At Risk
3
num Events
3
group Id
EG008
num Affected
14
num At Risk
18
num Events
14
group Id
EG009
num Affected
2
num At Risk
4
num Events
2
group Id
EG010
num Affected
19
num At Risk
29
num Events
19
group Id
EG011
num Affected
4
num At Risk
6
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Anisocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
1
num At Risk
117
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Coagulopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Increased tendency to bruise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
3
num At Risk
117
num Events
3
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
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
9
num At Risk
117
num Events
9
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
5
num At Risk
18
num Events
5
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
1
num At Risk
29
num Events
1
group Id
EG011
num Affected
2
num At Risk
6
num Events
2
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
4
num At Risk
117
num Events
4
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
7
num At Risk
29
num Events
7
group Id
EG011
num Affected
2
num At Risk
6
num Events
2
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
1
num At Risk
117
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
2
num At Risk
117
num Events
2
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
4
num At Risk
4
num Events
4
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
7
num At Risk
18
num Events
7
group Id
EG009
num Affected
2
num At Risk
4
num Events
2
group Id
EG010
num Affected
15
num At Risk
29
num Events
15
group Id
EG011
num Affected
3
num At Risk
6
num Events
3
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Splenomegaly
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
69
num At Risk
117
num Events
69
group Id
EG005
num Affected
3
num At Risk
5
num Events
3
group Id
EG006
num Affected
3
num At Risk
4
num Events
3
group Id
EG007
num Affected
2
num At Risk
3
num Events
2
group Id
EG008
num Affected
14
num At Risk
18
num Events
14
group Id
EG009
num Affected
2
num At Risk
4
num Events
2
group Id
EG010
num Affected
23
num At Risk
29
num Events
23
group Id
EG011
num Affected
5
num At Risk
6
num Events
5
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Angina pectoris

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
8
num At Risk
117
num Events
8
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
2
num At Risk
18
num Events
2
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
2
num At Risk
29
num Events
2
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
2
num At Risk
18
num Events
2
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
1
num At Risk
117
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
1
num At Risk
117
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
1
num At Risk
29
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Cardiac failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
117
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
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
1
num At Risk
117
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
18
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
29
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Sinus tachycardia

time Frame

From first dose of study drug through 30 days after the last dose of study drug (Up to 116 Months)

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

Preserved source evidence · Not medical advice