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NCT03948763 · ADVERSE EVENTS

Adverse events

A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) · Source last updated 2025-01-28

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
Up to approximately 27 months
Other-event reporting threshold
5%

All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: V941 Monotherapy

V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles

1 / 33 / 31 / 3
Part 1: V941 + Pembrolizumab

V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles

6 / 1515 / 1512 / 15
Part 1: V941 + Pembrolizumab (Switched Over From V941 Monotherapy)

Participants who received the initial treatment of V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and developed progressive disease were eligible to switch over to V941 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles.

0 / 10 / 11 / 1
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)

V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles

5 / 2020 / 2013 / 20
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)

V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles

7 / 1616 / 1612 / 16
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)

V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles

9 / 1615 / 1613 / 16

Group identifiers: EG000: Part 1: V941 Monotherapy · EG001: Part 1: V941 + Pembrolizumab · EG002: Part 1: V941 + Pembrolizumab (Switched Over From V941 Monotherapy) · EG003: Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab) · EG004: Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab) · EG005: Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Duodenitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Enterocolitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Haematemesis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Ileus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Small intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Asthenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Death
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
      num Events
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
      num Events
      2
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      2
    term
    Biliary obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Jaundice cholestatic

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      15
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      16
      num Events
      4
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Hyperthyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Eyelid ptosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Vitreous floaters
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      15
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Abdominal pain lower
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
      num Events
      2
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Abdominal tenderness
Complete source fields
description
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Part 1: V941 Monotherapy
  2. deaths Num Affected
    12
    deaths Num At Risk
    15
    description
    V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
    id
    EG001
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    6
    serious Num At Risk
    15
    title
    Part 1: V941 + Pembrolizumab
  3. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Participants who received the initial treatment of V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and developed progressive disease were eligible to switch over to V941 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles.
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Part 1: V941 + Pembrolizumab (Switched Over From V941 Monotherapy)
  4. deaths Num Affected
    13
    deaths Num At Risk
    20
    description
    V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
    id
    EG003
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    5
    serious Num At Risk
    20
    title
    Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
  5. deaths Num Affected
    12
    deaths Num At Risk
    16
    description
    V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
    id
    EG004
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    7
    serious Num At Risk
    16
    title
    Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
  6. deaths Num Affected
    13
    deaths Num At Risk
    16
    description
    V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
    id
    EG005
    other Num Affected
    15
    other Num At Risk
    16
    serious Num Affected
    9
    serious Num At Risk
    16
    title
    Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      15
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      16
      num Events
      4
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      20
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Hyperthyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Eyelid ptosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Vitreous floaters
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      15
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Abdominal pain lower
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
      num Events
      2
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Abdominal tenderness
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Duodenitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Enterocolitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Haematemesis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Ileus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Small intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Asthenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Death
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
      num Events
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      16
      num Events
      2
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      2
    term
    Biliary obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Jaundice cholestatic
time Frame
Up to approximately 27 months

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

Preserved source evidence · Not medical advice